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DOH 681-018 April 2017 Page 1 of 47
Waived Tests and CPT Codes This list is for informational purposes only and may not accurately represent current CMS CPT codes.
Please verify your tests waived status and CPT code prior to implementing testing.
Test Name/Specific Test System Manufacturer Approved
Aerobic/Anaerobic/Viral Panel - Respiratory FilmArray Respiratory Panel 2.0 EZ (RP EZ) (nasopharyngeal) Biofire Diagnostics, LLC Pending Albumin
Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP, Renal) Abaxis, Inc 82040QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) Abaxis, Inc. 82040QW
Alkaline Phosphatase (ALP) Abaxis Piccolo Blood Chem Analyzer WB (CMP, Chem 13) Abaxis, Inc 84075QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) (WB) Abaxis, Inc. 84075QW
Bilirubin, Total Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP) Abaxis, Inc 82247QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc)(WB) Abaxis, Inc. 82247QW
Alere NMP22 BladderChek Test Alere 86386QW BTA stat Test (for home use) Bion Diagnostic Sciences 86294QW LifeScan Status BTA Polymedco, Inc 86294QW Maritech BladderCheck Maritech, Inc. 86386QW
BUN (Blood Urea Nitrogen) Abaxis Piccolo Blood Chemistry Analyzer (Chem 6 and 13 Panels, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 84520QW
Abaxis Piccolo xpress Chemistry Analyzer WB (Chem 6, 13, Kidney Panels, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 84520QW
Abaxis Piccolo Point of Care Chemistry Analyzer WB (Lipid Panel, Lipid Panel Plus) Abaxis, Inc 82465QW
Accu-Check InstantPlus Cholesterol Test System Roche/Boehringer Mannheim 82465QW Accucheck Instant Plus Dual Testing System Roche Diagnostics 82465QW Advanced Care Cholesterol Measuring System Johnson & Johnson 82465QW Alere Cholestech LDX (cholesterol)(WB) Alere, Inc 84465QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82465QW Biomedix Inc Q Steps Biometer G/C Dual Monitoring System Biomedix, Inc. 82465QW ChemTrak AccuMeter Cholesterol Test System ChemTrak 82465QW Cholestech LDX (Must have software version 1.40 or above) Cholestech 82465QW ENA.C.T. Total Cholesterol & PDU ActiMed Laboratories, Inc 82465QW Infopia USA LipidPro Infopia Co Ltd 82465QW Infopia USA LipidPro Professional Lipid Profile and Glucose Measuring System Infopia Co Ltd 82465QW
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System Infopia Co, Ltd 82465QW
Lifestream Plus Cholesterol Monitor Lifestream Technologies 82465QW Lifestream Technologies Cholesterol Monitor Lifestream Technologies 82465QW Lifestream Technologies Personal Cholesterol Monitor for cholesterol Lifestream Technologies, Inc. 82465QW
Polymer Technology Systems Bioscanner, Bioscanner Plus, and Bioscanner 2000 PTS
Polymer Technology Systems Cardiochek Plus, Cardiochek Home Use, Home Test System, and Cardiochek PA Analyzer test strips. CardioChek Home Chol+HDL+Glu Test strips Polymer Technology Systems,
Inc
82465QW
-PTS Panels Lipid Panel test strips 82947QW -CardioChek Home Lipid Panel test strips 82947QW
DOH 681-018 April 2017 Page 4 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Roche Diagnostics Accutrend Plus System WB Roche Diagnostics 82465QW Wako APOLOWAKO Analyzer Wako Chemicals USA 82465QW
Creatinine Abaxis Piccolo Blood Chem Analyzer WB (Chem 6 and 13 Panels, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 82565QW
Abaxis Piccolo xpress Chem Analyzer WB (Chem 6, 13, Kidney Panels, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 82565QW
Abbott i-STAT Crea Cartridge (WB) i-STAT Corporation 82565QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82565QW Akray SPOTCHEM EX Chem Analyzer (WB) Polymedco, Inc 82565QW Siemens Clinitek 50 Urine Chemistry Analyzer (see also under Urinalysis) Bayer 82570QW
Siemens MICROABLUSTIX Reagent Strips Bayer 82570QW Siemens MultiStix PRO 10LS, PRO 11 and PRO 7G Reagent Strips (urine dipstick and urine creatinine nonautomated) Bayer 82570QW
Drugs of Abuse (Use G0477QW for visually read devices or G0478QW for instrument read devices) 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z Split Key Cup II(amphetamines, cocaine metabolites, MDMA, methamphetamines, opiates, PCP, THC)
Biosite Inc 80305QW
Abbott Diagnostics Signify ER Drug Screen Test(amphetamines, barbiturates, benzodiazepines,cocaine metabolites, MDMA, opiates, oxycodone, PCP, propoxyphene, THC, tricyclic antidepressants)
Aeon Multi-Drug Urine Test Cup and DipCard (amphetamines, barbituates, benzodiapzepines, buprenorphine, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants, EDDP)
Healgen Scientific Limited 80305QW
AimScreen Multi-Drug Urine Dip Card, Dip Device CLIA Waived and Test Cup (Amphetamines, Benzodiazepines, Cocaine metaboities, Cannabinoids, Methamphetamines, Oxycodone, Morphine, Barbituates, Buprenorphine, MDMA, PCP, Methadone)
Healgen Scientific Limitied 80305QW
Alatex Scientific Peace of Mind Marijuana Home Drug Test Advantage Diagnostics Corp 80305QW Alere Toxicology Service Alere iCup DxPro2 Multi-Drug Test Cup (Amphetamines, Barbiturates, Benzodiazepines, Benzodiazepines, Cocaine metabolities, Cannabinoids (THC), Methamphtamines, MDMA, Morphine, PCP, Oxycodone, Buprenorphine, Methadone, Tricyclic antidepressants)
Guanhzhou Wondfo Biotech., LTD. 80305QW
Marijuana & Cocaine Home Drug Test (OTC) Alatex Scientific 80305QW Multiple Drugs of Abuse Test Advantage Diagnostics Corp 80305QW Alere iCassette Drug Screen (amphetamines, cocaine metabolites, Methamphetamines, Opiates, PCP, THC) Biosite Inc 80305QW
Alere Toxicology Services Drugs of Abuse Cup (amphetamines, cocaine metabolites, THC, methamphetamines, MDM A, opiates, PCP)
Alere San Diego, Inc 80305QW
Alere Tox Screen Drugs of Abuse Test Cup(amphetamines, cannabinoids, cocaine metabolites, methamphetamines, opiates, PCP, MDMA)
Alere, Inc 80305QW
Alfa Scientific Designs, Inc Confidential Drug Test-Multi Drugs of Abuse Urine (amphetamines, cocaine metabolites, morphine, THC, MDMA)
Alfa Scientific Designs, Inc 80305QW
Alfa Scientific Designs, Inc Instant View Multi Drug of Abuse Urine Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, morphine, methadone, PCP, tricyclic antidepressants, THC, MDMA)
Alfa Scientific Designs, Inc 80305QW
Alfa Scientific Designs, Inc Instant View Multi Drug of Abuse Urine Cup Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, morphine, methadone, PCP, tricyclic antidepressants, THC, MDMA)
Alfa Scientific Designs, Inc 80305QW
Alfa Scientific Designs, Inc Instant Verdict Multi Drug of Abuse Urine Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, morphine, methadone, PCP, tricyclic antidepressants, THC, MDMA)
Alfa Scientific Designs, Inc 80305QW
Alfa Scientific Designs, Inc Instant Verdict Multi Drug of Abuse Urine Cup Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, morphine, methadone, PCP, tricyclic antidepressants, THC, MDMA)
Alfa Scientific Designs, Inc 80305QW
Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cup Test (morphine, Oxycodone) Alfa Scientific Designs, Inc 80305QW
Alfa Scientific Designs, Inc. Instant-View Multi Drug of Abuse Urine Test Cup(amphetamines, barbiturates, benzodiazepines, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, opiates, PCP, tricyclic antidepressants, THC)
Alfa Scientific Designs, Inc 80305QW
Alfa Scientific Designs, Inc. Instant-View Multi Drug of Abuse Urine Test Panel(amphetamines, barbiturates, benzodiazepines, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, opiates, PCP, tricyclic antidepressants, THC)
Alfa Scientific Designs, Inc 80305QW
Alfa Scientific Designs Instant-View Drug of Abuse Urine Cassette Test (morphine, Oxycodone) Alfa Scientific Designs, Inc 80305QW
Alfa Scientific Designs, Inc Multi Drug of Abuse Urine Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, morphine, methadone, PCP, tricyclic antidepressants, THC, MDMA)
Alfa Scientific Designs, Inc 80305QW
DOH 681-018 April 2017 Page 7 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Alfa Scientific Designs, Inc Multi Drug of Abuse Urine Cup Test (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, morphine, methadone, PCP, tricyclic antidepressants, THC, MDM
Alfa Scientific Designs, Inc 80305QW
Amedica Biotech Amedica Drug Test Cup (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, methadone, opiates, oxycodone, PCP, tricyclic antidepressants, THC, MDMA)
Amedica Biotech Inc. 80305QW
Amedica Biotech The Amedica Home Drug Test Cup (barbiturates, amphetamines, benzodiazepines, cocaine metabolites, methamphetamines, methadone, opiates, oxycodone, PCP, tricyclic antidepressants, THC, MDMA)
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, THC, methamphetamines MDMA, morphine, methadone, PCP, tricyclic antidepressants, oxycodone)
Guangzhou Wondfo Biotech Co 80305QW
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, THC, methamphetamines MDMA, morphine, methadone, PCP, tricyclic antidepressants, oxycodone)
Guangzhou Wondfo Biotech Co 80305QW
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, THC, methamphetamines, MDMA, morphine, opiates, PCP, oxycodone, buprenorphine)
Guangzhou Wondfo Biotech Co 80305QW
American Screening Corp Discover Drug Test Cups/Cards (amphetamines, barbiturates, benzodiazepines, buprenorphine, EDDP, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, propoxyphene, tricyclic antidepressants)
American Screening Corp Reveal Mini Drug Testing Cups (amphetamines, barbiturates, benzodiazepines, buprenorphine, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, propoxyphene, PCP, tricyclic antidepressants)
UCP Biosciences, Inc 80305QW
APC Work Force solutions ZeroChaos Multi Drug Screen Cup – professional (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)
Tianjin New Bay Bioresearch 80305QW
Applied Biotech Drug Free @Home:THC (OTC) Applied Biotech, Inc 80305QW Applied Biotech Drug Free @Home:Cocaine Test (OTC) Applied Biotech, Inc 80305QW AssureTech Strip, Dip Card, Quick Cup, Turn-Key Split Cup (Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine, PCP)
CLIA Screen In-Vitro Multi-Drug Urine Test Dip Card and Test Cup (amphetamines, cocaine metabolites, barbituates, benzodiazepines, MDMA, buprenorphine, EDDP, methadone, methamphetamines, morphine, oxycodone, PCP, THC, tricycylic antidepressants)
Healgen Scientific 80305QW
DOH 681-018 April 2017 Page 12 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
CLIA-X Multiple Drug Cup Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)
Tianjin New Bay Bioresearch Co 80305QW
CLIAwaived, Drug Test Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, oxycodone, PCP, tricyclic antidepressants)
Guangzhou Wondfo Biotech 80305QW
CLIAwaived, Instant Drug Test Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, morphine, oxycodone, PCP, tricyclic antidepressants)
Guangzhou Wondfo Biotech 80305QW
CLIAwaived Rapid Dip Drug Test (buprenorphine) Branan Medical Corp 80305QW CLIAwaived Rapid Drug Test Cup (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)
Biosite, Inc / Alere 80305QW
CLIAwaived Inc. Rapid Drug Test Cup Cassette Dip Card format (amphetamines, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, oxycodone, PCP, propoxyphene, tricyclic antidepressants)
Branan Medical Corp 80305QW
CLIAwaived Rapid Drug Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP)
Branan Medical Corp 80305QW
CLIAwaived Single Drug Dipstick Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)
Branan Medical Corp 80305QW
CLIAwaived Single Drug Dipstick Test (buprenorphine) Branan Medical Corp 80305QW Clinical Reference Intelligent Transport Cup (OTC) (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)
Confirm Biosciences Reli On Multi-Drug Urine Cup Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)
Alfa Scientific Designs, Inc 80305QW
Confirm Biosciences Reli On Urine Screening Test (THC, cocaine metabolites, methamphetamines, morphine) Alfa Scientific Designs, Inc 80305QW
CR3 Keyless Split Sample Cup Morphine-Oxazepam-Cup System ( benzodiazepines, morphine)
Guangzhou Wondfo Biotech Co., Ltd 80305QW
CVS/Pharmacy Inc. CVS Home Drug Test (amphetamines,barbituates, benzodiapines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)
First Check Diagnostics, LLC 80305QW
Devon Medical CentralCheck Multiple Drug Cup Test (professional use) (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)
Tianjin New Bay Bioresearch 80305QW
Diagnostic Test Group Clarity Multiple Drug Screen Cups (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)
UCP Biosciences, Inc 80305QW
Diagnostic Test Group Clarity Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)
Alfa Scientific Designs, Inc 80305QW
Diagnostic Test Group Clarity Multi-Drug Test Cards (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)
UCP Biosciences, Inc 80305QW
Diagnostic Test Group Clarity Simple Drug Screening Cups (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)
UCP Biosciences, Inc 80305QW
Discover Plus Multi-Panel Drug Test Cups and Cards (EDDP) UCP Biosciences, Inc 80305QW Drug Detection Devices Ltd Screeners AutoCup Clinical (OTC) (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)
DrugSmart Multi-Panel Drug Screen Cup with OPI 2000 Test (Amphetamines, Barbiturates, Benzodiazepines, Burprenorphine, Cocanie metabolities, MDMA, Methamphetamines, Methadone, Opiates, Oxycodone, Propoxyphene, Cannabinoids, Tricyclic antidepressants, Propoxyphene)
Chemtron Biotech, Inc. 80305QW
DOH 681-018 April 2017 Page 14 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Easy At Home Medical, LLC Easy@Home Multi Drug-Urine Test Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, methamphetamines, MDMA, morphine, oxycodone, PCP)
Guangzhou Wondfo Biotech Co., Ltd 80305QW
Easy At Home Medical, LLC Easy@Home Multi Drug-Urine Test Cup (methadone, tricyclic antidepressants)
Guangzhou Wondfo Biotech Co., Ltd 80305QW
Easy At Home Medical, LLC Easy@Home Multi Drug-Urine Test Panel(amphetamines, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, methamphetamines, MDMA, morphine, oxycodone, PCP)
Guangzhou Wondfo Biotech Co., Ltd 80305QW
Easy @ Home Cannabinoids Single Panel Easy at Home Medical, LLC 80305QW Easy At Home Medical, LLC Easy@Home Multi Drug-Urine Test Panel (methadone, tricyclic antidepressants)
Guangzhou Wondfo Biotech Co., Ltd 80305QW
EGENS Biotechnology Urine Test Cup (Methamphetamine /amphetamine, and Morphine)
Nantong Egens Biotech Co., LTD. 80305QW
EGENS Biotechnology Co., Ltd,. EGENS Urine Test Marijuana (THC) Cup, DipCard, and Cassette
Nantong Egens Biotech Co., LTD. 80305QW
EGENS Biotechonology Co., Ltd,. EGENS Urine Test MDMA Cup, and DipCard
Nantong Egens Biotech Co., LTD. 80305QW
Ekla Corporation NOVAPLUS Buprenorphine Drug Test Cup S.D. Biotek, Llc 80305QW Elka Corporation NOVAPLUS Drug Test Cup(amphetamines, barbiturates, benozodiazepines, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants, THC)
S.D. Bioteck, Llc 80305QW
ELKA Corporation NOVAPLUS MDMA and OPI Drug Test Cup Urine, Cup format(MDMA, opiates)
Tianjin New Bay Bioresearch Co., Ltd 80305QW
eScreen, Inc. mCheck Multi-Line Screen Test Device: cocaine metabolites, methamphetamines, THC, opiates, PCP, amphetamines
Innovacon, Inc. 80305QW
Express Diagnostics International Inc DrugCheck Waive Drug Test Cards (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)
Express Diagnostics DrugCheck Waive TC Multiple Drug Cup Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)
Tianjin New Bay Bioresearch co 80305QW
First Check 12 Drug Cup Test(amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)
First Check Diagnostics, LLC 80305QW
DOH 681-018 April 2017 Page 15 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
First Check Diagnostics LLC, Home Drug Test(amphetamines, cannabinoids, tricyclic antidepressants, cocaine metabolites, methamphetamines, opiates, PCP, barbiturates, benzodiazepines, methadone, oxycodone, MDMA
Amedica Biotech, Inc 80305QW
First Check Home Drug Test for Marijuana Acon Laboratories 80305QW First Check Multi Drug Cup (amphetamines, THC, Cocaine metabolites, MDMA, methamphetamines, opiates, PCP) Worldwide Medical, LLC 80305QW
First Check Multi Drug Cup 12 (OTC)(amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone, PCP, tricyclic antidepressants)
First Check Diagnostics, LLC 80305QW
First Sign Drug of Abuse Dip Card and Cup Test (MDMA, EDDP, Nortriptyline) W.H.P.M., INC
Forefront Diagnostics: DrugFree Home THC and COC Test Kit Forefront Diagnostics, Inc 80305QW Instacheck Drug Screen THC Applied Biotech, Inc. 80305QW Instacheck Multi-Drug Screen Panel (THC/COC) Forefront Diagnostics, Inc 80305QW Germaine Laboratories, Inc., SafeCup 14 Multi-Drug Urine test Cup (EDDP, Tricyclic antidepressants, Amphetamines, Cociane metabolites, THC, Methamphetamines, Morphine, Oxycodone, Buprenorphine, MDMA, PCP, Methadone, Benzodiazepines, Barbiturates)
Healgen Amphetamine Test Cassette Healgen Scientific, Llc 80305QW HealgenAmphetamine Test Cup Healgen Scientific, Llc 80305QW Healgen Amphetamine Test Dip Card Healgen Scientific, Llc 80305QW Healgen Amphetamine Test Strip Healgen Scientific, Llc 80305QW Healgen EDDP (Methadone Metabolite) Test Cassette Healgen Scientific, Llc 80305QW Healgen EDDP (Methadone Metabolite) Test Cup Healgen Scientific, Llc 80305QW Healgen EDDP (Methadone Metabolite) Test DipCard Healgen Scientific, Llc 80305QW Healgen EDDP (Methadone Metabolite) Test Strip Healgen Scientific, Llc 80305QW Healgen Oxazepam Test Cassette Healgen Scientific, Llc 80305QW Healgen Oxazepam Test Cup Healgen Scientific, Llc 80305QW Healgen Oxazepam Test Dip Card Healgen Scientific, Llc 80305QW Healgen Oxazepam Test Strip Healgen Scientific, Llc 80305QW Healgen Oxycodone Test Cassette Healgen Scientific, Llc 80305QW Healgen Oxycodone Test Cup Healgen Scientific, Llc 80305QW Healgen Oxycodone Test Dip Card Healgen Scientific, Llc 80305QW Healgen Oxycodone Test Strip Healgen Scientific, Llc 80305QW Healgen COC One Step CocaineTest Cassette Healgen Scientific, Llc 80305QW Healgen COC One Step Cocaine Test Cup Healgen Scientific, Llc 80305QW Healgen COC One Step Cocaine Test Dip Card Healgen Scientific, Llc 80305QW Healgen COC One Step Cocaine Test Strip Healgen Scientific, Llc 80305QW Healgen THC One Step Marijuana Test Cassette Healgen Scientific, Llc 80305QW Healgen THC One Step Marijuana Test Cup Healgen Scientific, Llc 80305QW Healgen THC One Step Marijuana Test Dip Card Healgen Scientific, Llc 80305QW Healgen THC One Step Marijuana Test Strip Healgen Scientific, Llc 80305QW Healgen mAMP One Step Methamphetamine Test Cassette Healgen Scientific, Llc 80305QW Healgen mAMP One Step Methamphetamine Test Cup Healgen Scientific, Llc 80305QW Healgen mAMP One Step Methamphetamine Test Dip Card Healgen Scientific, Llc 80305QW Healgen mAMP One Step Methamphetamines Test Strip Healgen Scientific, Llc 80305QW Healgen Methadone Test Cassette Healgen Scientific, Llc 80305QW Healgen Methadone Test Cup Healgen Scientific, Llc 80305QW Healgen Methadone Test Dip Card Healgen Scientific, Llc 80305QW Healgen Methadone Test Strip Healgen Scientific, Llc 80305QW Healgen MOP One Step MorphineTest Cassette Healgen Scientific, Llc 80305QW Healgen MOP One Step MorphineTest Cup Healgen Scientific, Llc 80305QW Healgen MOP One Step Morphine Test Dip Card Healgen Scientific, Llc 80305QW Healgen MOP One Step Morphine Test Strip Healgen Scientific, Llc 80305QW Healgen Morphine Test Cassette Healgen Scientific, Llc 80305QW Healgen Morphine Test Cup Healgen Scientific, Llc 80305QW Healgen Morphine Test Dip Card Healgen Scientific, Llc 80305QW Healgen Morphine Test Strip Healgen Scientific, Llc 80305QW Healgen MDMA Test Cassette LSI International Inc. 80305QW Healgen MDMA Test Cup LSI International Inc. 80305QW Healgen MDMA Test Dip Card LSI International Inc. 80305QW Healgen MDMA Test Strip LSI International Inc. 80305QW Healgen Multi-Drug Urine Test Cup and Dip Card (EDDP, Tricyclic anti-depressants) Healgen Scientific LLC 80305QW
Healgen Nortriptyline Test Cassette (Tricyclic Anitdepressants) Healgen Scientific, Llc 80305QW Healgen Nortriptyline Test Cup (Tricyclic Anitdepressants) Healgen Scientific, Llc 80305QW
DOH 681-018 April 2017 Page 17 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Healgen Nortriptyline Test Dip Card (Tricyclic Anitdepressants) Healgen Scientific, Llc 80305QW Healgen Nortriptyline Test Strip (Tricyclic Anitdepressants) Healgen Scientific, Llc 80305QW Healgen Buprenorphine Test Cassette Healgen Scientific, Llc 80305QW Healgen Buprenorphine Test Cup Healgen Scientific, Llc 80305QW Healgen Buprenorphine Test Dip Card Healgen Scientific, Llc 80305QW Healgen Buprenorphine Test Strip Healgen Scientific, Llc 80305QW Healgen PCP Test Cassette LSI International Inc. 80305QW Healgen PCP Test Cup LSI International Inc. 80305QW Healgen PCP Test Dip Card LSI International Inc. 80305QW Healgen PCP Test Strip LSI International Inc. 80305QW Healgen Propoxyphene Test Cassette Healgen Scientific, Llc 80305QW Healgen Propoxyphene Test Dip Card Healgen Scientific, Llc 80305QW Healgen Propoxyphene Test Cup Healgen Scientific, Llc 80305QW Healgen Propoxyphene Test Strip Healgen Scientific, Llc 80305QW Healgen Secobarbital Test Cassette Healgen Scientific, Llc 80305QW
IND Home Amphetamine Test (strip format) IND Diagnostic, Inc 80305QW IND Home Amphetamine, Marijuana, Cocaine, Methamphetamines, Morphine Test (cassette format) IND Diagnostic, Inc 80305QW
IND Home Cocaine and Methamphetamines Test (strip format) IND Diagnostic, Inc 80305QW IND Home Marijuana Test (strip format) IND Diagnostic, Inc 80305QW IND Home Drug Test Multi-Panel Strip and lCassette Formats (amphetamines, cocaine metabolites, methamphetamines, morphine, THC)
IND Diagnostic, Inc 80305QW
Innovacon Integrated E-Z Split Key Cup II (amphetamines cocaine metabolites, THC, methamphetamines, MDMA, opiates, PCP)
Innovacon 80305QW
Innovacon Multi-Clin Drug Screen Test Device (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, MDMA, morphine, oxycodone, PCP, propoxyphene, tricyclic antidepressants)
Innovacon, Inc 80305QW
Insight Medical Drug of Abuse Cassette/Cup (morphine, oxycodone) Alfa Scientific Designs, Inc 80305QW
Insight Medical Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Jant Pharmacal Accutest Multi X Drug Cup Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)
Kasaac Laboratories, Inc Kasaac Laboratories Buprenorphine Drug Test (opiates)
Tianjin New Bay Bioresearch Co., Ltd 80305QW
Kasaac Laboratories Multi (MDMA ands OPI) Drug Test Cup Urine, Cup format(MDMA, opiates)
Tianjin New Bay Bioresearch Co., Ltd 80305QW
LifeSign Home Drug Tests:Marijuana, Cocaine Metabolites Princeton Biomeditech Corp 80305QW LifeSign Home Drug Tests:Marijuana, Opiates, Cocaine Metabolites, and Methamphetamines Princeton Biomeditech Corp 80305QW
MedDirect Inc ProXam Drug Test Cards(amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)
Medical Distribution Group Inc., Identify Diagnostics Home Drug Test Cards and Cups (Buprenorphine, Amphetamines, Cocaine metabolites, EDDP Methamphetamines, MDMA, Oxycodone, Opiates, Morphine, PCP, THC, Benzodiazepines, Methadone, Barbiturates, Tricyclic antidepressants, Propoxyphene)
UCP Biosceinces, Inc 80305QW
Medical Distribution Group Inc., Identify Diagnostics Drug Test Cards and Cups (EDDP) UCP Biosciences, Inc 80305QW
Medimpex Q Test Buprenorphine Drug Cup Test (opiates) Tianjin New Bay Bioresearch Co 80305QW
Medimpex Q Test Multi X Drug Cup Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)
Tianjin New Bay Bioresearch Co 80305QW
Micro Distributing II Ltd Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)
Alfa Scientific Designs, Inc 80305QW
Micro Distributing II Ltd STAT Cup3 One Step Drug Test Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, THC)
Guangzhou Wondfo Biotech 80305QW
Micro Distributing II Ltd STATDIP One Step Multi-Drug Urine Test Panel (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, THC)
Guangzhou Wondfo Biotech 80305QW
DOH 681-018 April 2017 Page 20 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Micro Distributing II Ltd STAT Cup One Step Drug Test Dip Care/Cup (amphetamines, barbiturates, benzodiazepines, THC, oxycodone)
Noble Medical Inc INSTA-SCREEN Multi-Drug Urine Test Cup (cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, PCP, tricyclic antidepressants)
Guangzhou Wondfo Biotech 80305QW
Noble Medical Inc INSTA-SCREEN Multi-Drug Urine Test Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, THC)
Guangzhou Wondfo Biotech 80305QW
Noble Medical Inc., INSTA-SCREEN Multi-Drug Test Cup II (Amphetamines, Cocaine metabolites, EDDP, Tricyclic antidepressants, THC, Methamphetamines, Morphine, Oxycodone, Buprenorphine, MDMA, PCP, Methadone, Benzodiazepines, Barbiturates)
Healgen Scientifc Limited 80305QW
DOH 681-018 April 2017 Page 22 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Nobel Medical Split-Specimen Cup (amphetamines, THC, cocaine metabolites, methamphetamines, MDMA, opiates, PCP) Nobel Medical 80305QW
On the Spot Drug Testing Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)
Alfa Scientific Designs, Inc 80305QW
On-Site Testing Specialists Inc. On-Site Testing Specialist Multi-Panel Drug Screen Cup and Dip Card Tests (amphetamines, barbituates, benzodiapines, buprenorphine, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, oxycodone, PCP, propoxyphene, THC, tricyclic antidepressants)
Chemtron Biotech, Inc. 80305QW
On-Site Testing Specialists Inc. On-Site Testing Specialist Multi-Panel Drug Screen Cup and Dip Card with OPI2000 Tests (amphetamines, barbituates, benzodiapines, buprenorphine, cocaine metabolites, MDMA, methamphetamines, methadone, morphine, oxycodone, opiates, PCP, propoxyphene, THC, tricyclic antidepressants)
Chemtron Biotech, Inc 80305QW
On-Site Testing Specialists Inc. On-Site Testing Specialist Drug Screen Cup Tests (amphetamines, barbituates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, MDMA, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)
Chemtron Biotech, Inc. 80305QW
On-Site Testing Specialists Inc. On-Site Testing Specialist Drug Screen Cup Tests with OPI 2000 (amphetamines, barbituates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, MDMA, methadone, methamphetamines, morphine, opiates, oxycodone, PCP, tricyclic antidepressants)
Phamatech At Home Drug Test Model: -9063/9063T (Amphetamine) -9064 (amphetamines) -9068/9068T (Methamphetamines) -9069 (methamphetamines) -9073/9073T (Cocaine Metabolites) -9074 (cocaine metabolites) -9078/9078T (THC) -9079 (THC) -9083/9083T (Opiates) -9084 (opiates) -9133/9133T (PCP) -9150/9150T (THC, Opiates, Cocaine Metabolites, Methamphetamine, Amphetamine) -9175 (Methamphetamines, THC) and Opiates)
Phamatech, Inc. 80305QW
DOH 681-018 April 2017 Page 23 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Phamatech QuickScreen At Home Drug Test Model: -9171 (Methamphetamines and Opiates) -9150 (Amphetamines, Cocaine Metabolites, Methamphetamines, Opiates, PCP and THC)
Phamatech, Inc 80305QW
Phamatech QuickScreen At Home 12 Drug Test Models 9308Z and 9308T(amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, MDMA, methamphetamines, oxycodone, opiates, PCP, THC)
Phamatech QuickScreen One Srep Amphetamines Screening Test Phamatech, Inc 80305QW Phamatech QuickScreen One Srep Cocaine Screening Test Phamatech, Inc 80305QW Phamatech Quick Screen One Srep Methamphetamine Screening Test Phamatech, Inc 80305QW
Phamatech Quick Screen One Srep Opiate Screening Test Phamatech, Inc 80305QW Phamatech Quick Screen One Srep PCP Screening Test Phamatech, Inc 80305QW Phamatech Quick Screen One Srep THC Screening Test Phamatech, Inc 80305QW Phamatech QuickScreen Pro Multi Drug Screening Test (Model 9177/ and 9178) Methamphetamine, THC, PCP, amphetamine, cocaine and opiates
Quest Products DrugHAWK Home Drug Test Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, THC, MDMA, methadone, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)
Amedica Biotech 80305QW
Quest Products DrugHAWK Home Drug Test Cup (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, methamphetamines, morphine, oxycodone, THC, tricyclic antidepressants)
Tianjin New Bay Bioresearch Co., Ltd. 80305QW
Quest Products, Inc. DrugHAWK MDMA and OPI Drug Test cup (urine) {Cup format} (MDMA, opiates)
Redwood Toxicology Laboratory Reditest Home Drug Test (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, THC, MDMA, methadone, methamphetamines, opiates, oxycodone, PCP, tricyclic antidepressants)
Biosite, Inc. 80305QW
Revolution Diagnostics, AccuSeal Pro Instant Test Cup (MDMA)(Opiates) Tianjin New Bay Bioresearch 80305QW
Revolution Dx AccuSeal Pro Instant Test Cup Test (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, THC, methadone, methamphetamines, morphine, oxycodone, PCP, tricyclic antidepressants)
Tianjin New Bay Bioresearch 80305QW
Revolution Dx AccuSeal Pro Instant Test Cup Test Buprenorphine Tianjin New Bay Bioresearch 80305QW Safecare Urine Test Cassette, Cup, Dip Card (Amphetamine, Cocaine metabolites, Marijuana)
Safecare Biotech (Hangzhou)Co.,LTD. 80305QW
SafeCup II Multi-Drug Urine Test Cup (EDDP, Tricyclic antidepressants, amphetamines, cocaine metabolites, THC, methamphetamines, morphine, oxycodone, buprenorphine, MDMA, PCP, methodone, benzodiazepines, barbituates)
Healgen Scientific 80305QW
Screen Tox Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, tricyclic antidepressants)
Alfa Scientific Designs, Inc 80305QW
SCI International New Choice At Home Drug Test (marijuana) strip format Ind Diagnostic Inc 80305QW
SDBiotek ForSure Buprenorphine Drug Cup Test (opiates) Tianjin New Bay Bioresearch 80305QW Statics Stik (THC, OP, COC, Ecstasy, Met) Princeton Biomeditech Corp 80305QW Syntron Bioresearch Quickscreen Buprenorphine Drug Cup (opiates) Tianjin New Bay Bioresearch 80305QW
Syntron Bioresearch Inc. Quikscreen Multi MDMA Drug Cup Test (MDMA, Opiates) Tianjin New Bay Bioresearch 80305QW
Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) (amphetamines, THC, Cocaine metabolites, methamphetamines, PCP, Tricyclic antidepressants, oxycodone, morphine, methadone, benzodiazepines, barbiturates)
Tianjin New Bay Bioresearch 80305QW
Tanner Scientific Inc., BluRapids Multi-Drug Urine Test Panel and Test Cup (amphetamines, THC, Cocaine metabolites, methamphetamines, PCP, Tricyclic antidepressants, opiates, MDMA, morphine, methadone, benzodiazepines, buprenorphine, barbiturates)
Guangzhou Wondfo Biotech Co., LTD. 80305QW
DOH 681-018 April 2017 Page 26 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Tanner Scientific Multi-Panel Drug Test Cup (Amphetamines, Barbituates, Benozodiapines, Buprenorphone, Cannabinoids, Cocaine Metabolites, EDDP, Methadone, Methamphetamines, MDMA, Morphone, Oxycodone, PCP, Propoxyphene, Tricyclic anitdepressants)
Co-Innovation Biotech Co., Ltd 80305QW
Tanner Scientific Inc., Platinum Line Multi-Panel Drug Test Cup (amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, opiates, oxycodone, PCP, propoxyphene, THC, tricyclic antidepressants)
UCP Biosciense, Inc 80305QW
TeenSavers Diag Teen Savers Home Drug Test (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, MDMA, methamphetamines, opiates, oxycodone, PCP, THC, tricyclic antidepressants)
Amedica Biotech, Inc 80305QW
Total Diagnostic Solutions Drug of Abuse Cassette/Cup (morphine, oxycodone) Alfa Scientific Designs, Inc 80305QW
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, MDMA, methamphetamines, morphine, PCP, THC, tricyclic antidepressants)
Alfa Scientific Designs, Inc 80305QW
Toxi-Cup MDMA and OPI (Opiates) Urine Drug Test Tianjin New Bay Bioresearch Co., Ltd. 80305QW
Toxi-Cup Urine Drug Test Cup (Amphetamines, Buprenophine, Methamphetamines, Oxycodone, PCP, THC, Benzodiazepines, Cocaine metabolites, Barbiturates, Morphine, Methadone, Tricyclic antidepressants)
Tianjin New Bay Bioresearch Co., Ltd. 80305QW
Transmetron Invitro Pro Drug Test Cups (amphetamines, barbiturates, benzodiazepines, buprenorphine, THC, cocaine metabolites, methampetamine, methadone, MDMA morphine,opiates, oxycodone, PCP, propoxyphene,tricyclic antidepressants)
Transmetron 80305QW
Transmetron, Inc. Invitro Pro Drug Test Cards (amphetamines, barbiturates, benzodiazepines, buprenorphine, THC, cocaine metabolites, methampetamine, methadone, MDMA morphine,opiates, oxycodone, PCP, propoxyphene,tricyclic antidepressants)
Follicle Stimulating Hormone (FSH) Acon Laboratories FSH Menopause Predictor Test Acon Laboratories, Inc. 83001QW Acon Laboratories FSH One Step Menopause Test Strip/Device Acon Laboratories, Inc. 83001QW Applied Biotech Menopause Predictor Test (FSH) Applied Biotech, Inc. 83001QW Applied Biotech Instacheck FSH Test (Professional) Applied Biotech, Inc. 83001QW Applied Biotech RU25 Plus FSH Menopause Test Applied Biotech, Inc. 83001QW Biotechnostix Rapid Response FSH One Step Menopause Test Device Acon Laboratories, Inc. 83001QW
BTNS Rapid Response FSH Menopausal Test Ind Diagnostics, Inc. 83001QW Genosis Fertell Female Fertility Test (FSH) Genosis, Inc. 83001QW Genua Menopause Monitor Test), Qualitative Genua 1944, Inc. 83001QW IND Diagnostic, Inc. One Step FSH Menopausal Test (midstream) IND Diagnostic, Inc. 83001QW IND Diagnostic, Inc. One Step Strip Style FSH Menopausal Test (professional use) IND Diagnostic, Inc. 83001QW
IND Diagnostic, Inc. One Step FSH Menopausal Test (Strip/Cassette) IND Diagnostic, Inc. 83001QW
IND Diagnostic, Inc. One Step Cassette Style FSH Menopausal Test (professional use) IND Diagnostic, Inc. 83001QW
Pan Probe Biotech Early Detect Menopause Test FSH Early Detect, Inc. 83001QW Phamatech Moments Menopause Check (FSH) Phamatech 83001QW QuantRx Biomedical QuantRx Female Fertility Test Quantrx Biomedical Corp 83001QW RAC Medical Clarity FSH One Step Menopause Test Device (professional use) Acon Laboratories, Inc. 83001QW
LNX Fructosamine Test System LXN Corporation 82985QW
LXN Duet Glucose Monitoring System (for fructosamine and glucose [see below] LXN Corporation 82985QW
LXN IN CHARGE Diabetes Control System (glucose monitoring device [see below] & fructosamine) LXN Corporation 82985QW
Gamma Glutamyl Transferase (GGT) Abaxis Piccolo Blood Chemistry Analyzer WB (Chem 6, Chem 13 Abaxis, Inc. 82977QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) Abaxis, Inc. 82977QW
DOH 681-018 April 2017 Page 31 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Abaxis Piccolo xpress Chemistry Analyzer WB (Chem 6, Chem 13, Liver) Abaxis, Inc. 82977QW
Glucose Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use Various 82962
Abaxis Piccolo Blood Chem Analyzer WB(Chem 6, Chem 13, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 82947QW
Abaxis Piccolo Point Of Care Chemistry Analyzer (Lipid Panel Reagent Disc) Glucose Abaxis, Inc. 82947QW
-Post glucose dose 82950QW -GTT 3 spec 82951QW -GTT ea additional sample >3 samples 82952QWea Jant Pharmacal Lipid Plus Lipid Profile and Glucose Measuring System Infopia Co, Ltd 82465QW
LXN Duet Glucose Monitoring System (for fructosamine [see above] and glucose) LXN Corporation 82962
LXN IN CHARGE Diabetes Control System (glucose monitoring device & fructosamine [see above]) LXN Corporation 82962
Nova Biomedical StatStrip Glucose Hospital Meter System Nova Biomedical Corporation Pending Polymer Technology Systems Cardiochek PA Analyzer PTS (prescription use)
Polymer Technology Systems, Inc. 82962
Polymer Technology Systems Cardiochek Plus, Cardiochek Home Use and Cardiochek PA Analyzer test strips
Polymer Technology Systems, Inc.
82947QW Polymer Technology Systems, Inc., CardioChek Home Test System (CardioChek eGLU test strips, CaridoChek Home Chol+HDL+Glu Test strips) -PTS Panels Glucose and eGLU test strips -Post glucose dose 82950QW -GTT 3 spec 82951QW
DOH 681-018 April 2017 Page 32 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
-GTT ea additional sample >3 samples 82952QW ea
StatStrip Xpress Blood Glucose Montoring System Nova Biomedial Corporation Pending Wako APOLOWAKO Analyzer (WB) Wako Chemicals USA
Abaxis Piccolo Point of Care Chemistry Analyzer WB (Lipid Panel/Lipid Panel Plus) Abaxis, Inc 83718QW
Accutech CholesTrak HDL Cholesterol Home Test AccuTech, LLC 83718QW Alere Cholestech LDX (HDL)(WB) Alere, Inc 83718QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 83718QW Cholestech LDX (Must have software version 1.40 or above) Cholestech 83718QW
DOH 681-018 April 2017 Page 33 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Infopia USA LipidPro Infopia Co Ltd 83718QW Infopia USA LipidPro Professional Lipid Profile and Glucose Measuring System Infopia Co Ltd 82465QW
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System Infopia Co, Ltd 83718QW
Polymer Technology Systems BioScanner, BioScanner Plus, Bioscanner 2000 for HDL Cholesterol
Polymer Technology Systems, Inc. 83718QW
Polymer Technology Systems Cardiochek Plus, Cardiochek Home Use and Cardiochek PA Analyzer test strips
-PTS Panels Lipid Panel test strips -CardioChek Home Lipid Panel test strips
Polymer Technology Systems, Inc. 83718QW
Polymer Technology Systems, Inc., CardioChek PA Home Test System (CardioChek Home Lipid Panel test strips, CaridoChek Home Chol+HDL+Glu test strips)
Polymer Technology Systems, Inc. 83718QW
Helicobacter Pylori Abbott FlexPack HP Test for whole blood Abbott Laboratories 86318QW Abbott Signify H. pylori (whole blood) Abbott Laboratories 86318QW Abbott Signify H. pylori Cassette (whole blood) Abbott Laboratories 86318QW Abbott TestPack Plus H. pylori (for whole blood) Abbott Laboratories 86318QW Acon Helicobacter pylori Rapid Test Device (WB) Acon Laboratories 86318QW Alere Clearview H.pylori Whole Blood Only Alere San Deigo, Inc 86318QW Alere Signify H.pylori Whole Blood Only Alere San Deigo, Inc 86318QW Alfa Sci. Designs Instant View H. pylori (WB) Alfa Scientific Designs, Inc. 86318QW Applied Biotech SureStep H. pylori WB test (WB) Applied Biotech 86318QW ARJ Pylo-Plus Urease Test (gastric biopsy tissue) ARJ Medical, Inc 87077QW Ballard Medical Products (Delta West) CLOtest for H. pylori in gastric biopsy tissue Ballard Medical Products 87077QW
Beckman Coulter Primary Care Diagnostics Flexsure H. pylori (whole blood) Beckman Coulter, Inc. 86318QW
Becton Dickinson LINK 2 H. pylori Rapid Test (for whole blood) Same as Boehringer Mannheim AccuStat H. pylori OneStep Becton Dickinson 86318QW
BTNX Inc Rapid Response H. pylori Rapid Test Device (WB) BTNX Inc. / Innovacon 86318QW Cardinal Hlth SP Brand Rapid Test H. pylori (WB) Applied Biotech, Inc. 86318QW ChemTrak AccuMeter H. pylori test for WB ChemTrak 86318QW CLIAwaived H. pylori Whole Blood Rapid Test Alfa Scientific Designs, Inc. 86318QW Clarity H. pylori Rapid Test Device (WB) Innovacon 86318QW De Healthcare Prod Truview H. pylori Test (WB) Applied Biotech, Inc. 86318QW Diagnostic Test Group Clarity H. pylori Rapid Test Device (WB) Princeton Biomeditech Corp 86318QW EarlyDetect H. pylori Whole Blood Rapid Test Alfa Scientific Designs Inc 86318QW Fisher Healthcare Sure-Vue H. pylori Test (WB) Innovacon 86318QW Germaine Laboratories AimStep H. pylori (WB) Acon Laboratories, Inc. 86318QW Germaine Laboratories AimStep H. pylori (WB) Princeton Biomeditech Corp. 86318QW GI Supply Div. Chek-Med Systems HP One (H. pylori in gastric biopsy tissue)
GI Supply Div. Chek-Med Systems 87077QW
GI Supply HP-FAST for H. pylori in gastric biopsy Mycoscience Labs, Inc. 87077QW Henry Schein OneStep+ H. pylori (whole blood) Applied Biotech, Inc. 86318QW Immunostics Detector H. pylori (WB) Princeton Biomeditech Corp 83618QW Instant Tech. iScreen H. pylori Rapid Test Device Acon Laboratories, Inc 86318QW Inverness BTNX Inc Rapid Response H. pylori (wb) Acon Laboratories, Inc 86318QW Inverness Medical Clearview H. pylori Test (WB) Innovacon, Inc. 86318QW Inverness Medical SIGNIFY H. pylori whole blood Innovacon, Inc. 86318QW JANT Accutest Rapid Urease test (H.pylori detection) ARJ Medical, Inc. Pending
DOH 681-018 April 2017 Page 34 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Jant Parmacal Accutest H. pylori rapid Test Device (WB) Innovacon 86318QW Jant Parmacal H. pylori WB Test Applied Biotech, Inc. 86318QW LifeSign H. pylori WB (for whole blood) Princeton BioMeditech Corp 86318QW LifeSign Status H. pylori (for WB) Princeton BioMeditech 86318QW McKesson H. pylori Test (WB) (Cassette) Alere 86318QW McKesson Medi-Lab Performance H. pylori (WB) Innovacon 86318WQ Med Inst.CorpPronto Dry H. pylori (gastric biopsy) Medical Instruments Corp 87077QW Medline H. pylori Test Cassette (whole blood) Alere 87077QW Merid. Biosci. ImmunoCard STAT! H.pylori (WB) Meridian Bioscience 86318QW Merid. Biosci. ImmunoCard STAT! HpSA (stool) Meridian Bioscience 87899QW Polymedco, Inc. Poly stat H. pylori (WB) Applied Biotech, Inc. 86318QW PreMaxim RadiScreen H. pylori (WB) Acon Laboratories, Inc 86318QW Princeton BioMeditech BioSign H.pylori WB Princeton BioMeditech Corp 86318QW Princeton BioMeditech BioSign H.pylori WB (OSOM H. pylori) {serum, plasma, whole blood} Princeton BioMeditech Corp 86318QW
Pro-Advantage by NDC H. pylori Device WB Innovacon, Inc 86318QW PSS Consult H. pylori Cassette WB finger stick only Alere 86318QA Quidel QuickVue H.pylori (WB) Quidel 86318QA Quidel QuickVue H. pylori gII Test (WB) Quidel 86318QW Quidel QuickVue One-Step H. pylori test for (WB) Quidel 86318QW Quidel QuickVue One-Step H. pylori II test (WB) Quidel 86318QW Remel RIM A.R.C. H. pylori Test (WB) Remel 86318QW Roche Diagnostics AccuStat H. pylori OneStep (WB) Roche Diagnostics 86318QW Select Medical Products Brand Rapid Test H. pylori Innovacon 86318QW Serim Pyloritek Test Kit for Helicobacter pylori in gastric biopsy tissue Serim 87077QW
Serim Pyloritek VP Test Kit (H.pylori) (WB) Serim Research Corporation 87077QW SmithKline FlexSure HP test for IgG antibodies to H. pylori in whole blood SmithKline Diagnostics, Inc. 86318QW
Stanbio RELY H.pylori Rapid Test (WB finger stick only) Alere 86318QW Trinity Uni-Gold H. pylori (whole blood) Trinity BioTech, PLC 86318QW Wampole Laboratories Clearview H. pylori II (WB) Applied Biotech, Inc. 86318QW
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Biotest Hemoglobin Measuring System Biotest 85018QW Clarity HbCheck Hemoglobin Testing System Acon Laboratories, Inc. 85018QW CLIAwaived Inc. Hemoglobin (Hb) Testing System CLIAwaived Inc. 85018QW Copper-sulfate (non-automated) Various 83026 Diaspect Hemoglobin Measuring System Diaspect Medical GMBH 85018QW EKF Diagnostic Hemo_Contol Measurement and Hemo_Control Microcuvettes EKF Diagnostic GMBH Pending
Hemocue Donor Hemoglobin Checker System Hemocue 85018QW Hemocue Hemoglobin System HemoCue 85018QW Hemocue Hemoglobin 201+/Hemocue Hemoglobin Microcuvette System Hemocue 85018QW
HemoCue Hb 201 DM Analyzing System Hemocue 85018QW HemoCue Hb 301 System Hemocue 85018QW GDS Diagnostics HemoSite Meter for Hgb GDS Diagnostics 85018QW GDS Technology STAT-Site M Hgb Test System (hemoglobin) GDS Technology 85018QW ITC HGB PRO Prof. Hemoglobin Testing System ITC 85018QW Mission Plus Hemoglobin (Hb) Testing System Acon Laboratories, Inc. 85018QW Stanbio Hemoglobin Analyzer Stanbio 85018QW Stanbio HemoPoint H2 Hemoglobin Measurement System Stanbio 85018QW Stanbio HemoPoint H2 DM Hemoglobin Measurement System (with data management) Stanbio 85018QW
Hepatitis C Virus Antibody OraQuick HCV Rapid Antibody Test and Oraquick HCV Visual Reference Panel Orasure Technologies 86803QW
OraQuick In-Home HIV Test (oral fluid) Orasure Technologies, Inc 86703QW Oraquick Rapid HIV-1 Antibody Test (HIV-1 antibodies) (finger stick & venipuncture WB) OraSure Technologies, Inc 86701QW
Trinity Biotech Uni-Gold Recombigen HIV Test (finger stick and venipuncture whole blood)
Trinity Biotech Manufacturing Limited 86701QW
Influenza Alere BinaxNOW Influenza A & B Card (nasopharyngeal, nasal wash/aspirate) Alere Scarborough, Inc 87804QA
Alere Influenza A & B Test (Nasal Swab only) Alere Scarborough, Inc 87502QW Alere I Influenza A & B Test (Direct Nasal Swab only) Alere Scarborough, Inc 87502QW
DOH 681-018 April 2017 Page 36 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Alere Scarborough Inc. Medline Influenza A & B Test Alere Scarborough, Inc 87804QA BD Veritor System, Rapid Flu A+B (nasal, nasopharyngeal) (also version with reader) Becton Dickinson and Co 87804QW
Binax NOW Flu A Test (Influenza A) Binax, Inc. 87804QW Binax NOW Flu B Test (Influenza B) Binax, Inc. 87804QW Binax NOW Influenza A&B Test (NP/nasal wash, nasal swabs) Binax, Inc. 87804QW BioSign Flu A+B test (nasal, nasopharyngeal) Princeton Biomeditech Corp. 87804QW BTNX Rapid Response Influenza A Test Cassette Sa Scientific Inc 87804QW BTNX Rapid Response Influenza B Test Cassette Sa Scientific Inc 87804QW Cepheid Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) Cepheid 87807QW
Clearview Exact II Influenza A & B (Nasal swabs only) Inverness Medical 87804QW Cobas Infulenza A/B Nucleic Acid Test for Use on the cobas Liat System IQUUM, INC 87804QW
EarlyDetect Pro Influenza A Test SA Scientific Inc 87804QW EarlyDetect Pro Influenza B Test SA Scientific Inc 87804QW Henry Schein OneStep+Influenza A&B Test Binax Inc 87804QW
LifeSign LLC, Status Flu A+B Princeton BioMeditech Corporation 87804QW
Medline Industries, Inc. Meidline Influenza A &B Test Alere Scarborough, Inc D/B/A Binax, Inc. 87804QW
Quidel QuickVue Influenza Test [Influenza A/B] Quidel Corporation 87804QW Quidel QuickVue Influenza A+B Test Quidel Corporation 87804QW Roche Molecular, cobas Liat System (cobas Liat Influenza A/B Assay) Iquum, Inc Pending
SA Scientific SAS Influenza A SA Scientific, Inc. 87804QW SA Scientific SAS Influenza B SA Scientific, Inc. 87804QW Sekisui Diagnostics LLC, OSOM Ultra Flu A Influence A/B 87804QW Sofia Analyzer & Influenza A+B FIA (nasal) Quidel Corp. 87804QW ZymeTX Zstatflu Test (Influenza A/B) ZymeTX, Inc. 87449QW
Ketones (Blood) Abbott Freestyle precision pro glucose and beta-ketone monitoring system Abbott Diabetes Care 82010QW
Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System (ketone) Abbott Diabetes Care Ind 82010QW
Nova Max Mini Glucose and B-Ketone Monitoring Nova Biomedical 82010QW Nova Max Plus Glucose and B-Ketone Monitoring Nova Biomedical 82010QW Polymer Technology Systems BioScanner/BioScaner PTS for Blood Ketones
Polymer Technology Systems, Inc. 82010QW
Lactic Acid KDK Corp Lactate Pro System OTC (Lactic Acid) KDK Corporation 83605QW
LDL Cholesterol
Polymer Technology Systems Cardiochek/Cardiochek PA Analyzer Polymer Technology System 83721QW
Lead ESA Biosciences LeadCare II Blood Lead Testing System (whole blood) ESA Biosciences, Inc. 83655QW
Lipid Profile (Cholesterol, HDL Cholesterol and Triglycerides)
DOH 681-018 April 2017 Page 37 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Abaxis Piccolo Point of Care Chemistry Analyzer (Lipid Panel Reagent Disc)(WB) Piccolo 80061QW
Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 80061QW Cholestech LDX (Software version 1.40 or above) Cholestech 80061QW Infopia USA LipidPro Lipid Profile Test Strips Infopia Co Ltd 80061QW Infopia USA LipidPro Professional Lipid Profile and Glucose Measuring System Infopia Co Ltd 82465QW
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System Infopia Co, Ltd 80061QW
Jant Pharmacal Lipid Plus Lipid Profile and Glucose Measuring System(LipidPro Lipid Profile test strips) Infopia Co, Ltd 80061QW
Jant Pharmacal Corp,LipidPlus Professional Lipid Profile and Glucose Measuring System Infopia Co, Ltd 80061QW
Jant Pharmacal Corp,LipidPlus Professional Lipid Profile and Glucose Measuring System(LipidPlus Lipid Profile test strips) Infopia Co, Ltd 80061QW
Jant Pharmacal LipidPlus lipid profile and glucose measuring system Infopia Co., Ltd 80061QW
Jant Pharmacal LipidPlus lipid profile and glucose measuring system(LipidPro Lipid Profile test strips) Infopia Co., Ltd 80061QW
Polymer Technology System, Inc., CardioChek Plus Test System (PTS Panels Lipid Panel test strips)
Polymer Technology Systems, Inc 80061QW
Polymer Technology Systems Bioscanner Plus (PTS Panels Lipid Panel Test Strips)
Polymer Technology Systems, Inc 80061QW
Polymer Technology Systems Cardiocheck and Cardiochek PA Analyzers (PTS Panels Lipid Panel Test Strips)
Polymer Technology Systems, Inc 80061QW
Polymer Technology Systems, Inc., CardioChek Home Test System (CardioChek Home Lipid Panel test strips)
Polymer Technology Systems, Inc 80061QW
Lithium Akers Laboratory Inc InstaRead Lithium System (finger stick or venipuncture whole blood) Akers Laboratories, Inc. 80178QW
ReliaLAB, Inc. InstaRead Lithium System (finger stick or venipuncture whole blood) Akers Laboratories, Inc. 80178QW
Luteinizing Hormone (LH) (see ovulation tests) BTNX Inc Rapid Response LH Ovulation Test Ind Diagnostic Inc Pending
Invernexx Medical Early Ovulation Predictor Stix Selfcare, Inc. 83002QW Saless Enterprises New Choice Ovulation Predictor (Cassette, Midstream) Ind Diagnostic Inc 83002QW
Wampole PreVue B. burgdorferi Antibody for Lyme Disease Antibodies Wampole 86618QW
Matrix Metalloproteinases-9 (MMP-9) Rapid Pathogen Screening, Inc. InflammaDry Rapid Pathogen Screening, Inc. 83516QW
Microalbumin Micral Chemstrip Roche/Boehringer Mannheim 82044QW Beckman Coulter ICON Microalb Beckman Coulter 82044QW Diag. Chemicals ImmunoDip Urinary Albumin Test Diagnostic Chemicals 82044QW Diagnostic Chemicals Urinary Albumin Screen Urine Dipstick (microalbumin)
Diagnostic Chemicals Limited (USA) 82044QW
DOH 681-018 April 2017 Page 38 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Genzyme Diagnostics OSOM ImmunoDip Urinary Albumin Test Genzyme Diagnostics 82044QW HemoCue Albumin 201 System (Albumin, Urinary) Hemocue AB 82043QW Siemens Clinitek 50 Chemistry Analyzer (see also under Urinalysis) Bayer 82044QW
Alfa Scientific Designs Fecal Occult Blood Self-Test Alfa Scientific Designs, Inc Pending Beckman Coulter Primary Care Diagnostics Gastroccult/Hemoccult Sensa Elite (gastric occult blood) Beckman Coulter, Inc. 82271QW
BTNX Inc. Rapid Response Fecal Occult Blood (FOB) Self Test Alfa Scientific Designs, Inc 82274QW/ G0328QW
Compliance Gold Fecal Occult Blood Test - ER Immunostics, INC. 82274QW / G0328QW
Eiken Chemical Co., LTD OC-Light S FIT (1) Eiken Chemial Co. LTD Pending Germaine Laboratories AimStep Immunological Fecal Occult Blood Test (iFOBT) New Bay Bioresearch Co Old 82274QW /
G0328QW
Hema Screen Specific iFOBT Immunostics, INC. 82274QW / G0328QW
Immunostics, Inc hema screen ER Immunostics, Inc 82274QW / G0328QW
Tanner Scientific iFOB One Step Rapid Test Zhejiang Orient Gene Biotech Co., Lts Pending
Osmolarity TearLab Corp TearLab Osmolarity System (tears) TearLab Corporation 83861QW
Osteoporosis
Ostex International Osteomark NTX Point-of-care prescription home use (collagen type I crosslink, N-Telopeptides (NTX) Ostex International, Inc. 82523QW
Ovulation Tests Visual color comparison tests for human LH Various 84830 BTNX Inc Rapid Response LH Ovulation Test Ind Diagnostic Inc Pending Luna Fertility Indicator (saliva) Luna Pending O2 Unlimited Donna Ovulation Tester (saliva) O2 Unlimited 87210QW Stesans Maybe?Mom Mini Ovulation Microscope (saliva) Maybe? M.O.M., Inc. 87210QW TCI Ovulation Tester (saliva) TCI New York 87210QW
PH All qualitative color comparison pH testing body fluids (other than blood) Various 83986QW
Common Sense Ltd Fem-V Test Kit (vag pH) Common Sense, Ltd 83986QW Common Sense Ltd VA-SENSE Kit (vag pH) Common Sense, Ltd 83986QW Common Sense Ltd Norma-Sense Vag Discharge pH Common Sense, Ltd 83986QW Common Sense Ltd VI-SENSE Acidity (vag pH) Common Sense, Ltd 83986QW Common Sense Ltd VS-SENSE Test (vag pH) Common Sense, Ltd 83986QW Dale Med Prod. RightLevel pH (gastric pH) EZ-NG LLC 83986QW Dale Med Prod. RightSpot pH (gastric pH) EZ-NG LLC 83986QW Duramed Pharmaceuticals AmniScreen Home Detection Liner Kit Common Sense, Ltd 83986QW Femtek Phem-Alert (vaginal pH) Femtek, LLC 83986QW Lil’ Drug Store Products Vagi-Screen Vaginal Health Test (vaginal pH) Lil’ Drug Store Products Inc 83986QW
Litmus Concepts FemExam Test Card (vaginal pH and amines) Litmus Concepts, Inc. 82120QW amines
Quidel QuickVue Advance pH and Amines Test Quidel Corporation 82120QW amines
RightBio Metrics, RightSpot Infant pH Indicator Right Bio Metrics 83986QW Phosphorus
Alere INRatio2 PT/INR (professional/home use) Alere, Inc 85610QW AvoSure PT System (prescription home use) Avocet Medical, Inc. 85610QW AvoSure PRO (Professional Use) Avocet Medical, Inc. 85610QW CoaguSense Prothrombin Time (PT/INR) Coagusense, Ind 85610QW CoaguSense Self-Test Protime/INR (Prescription Home Use) Coagusense, Inc. 85610QW Hemosense INRATIO System Hemosense, Inc. 85610QW International Technidyne Protime Microcoagulation System International Technidyne Corp 85610QW International Technidyne Protime Microcoagulation System ProTime 3 Cuvette International Technidyne Corp 85610QW
Lifescan Harmony INR Monitoring System (Prescription Home Use and Professional Use) (reports INR only) Lifescan 85610QW
Lifescan Rubicom Prothrombin Time Monitoring System Lifescan, Inc. 85610QW Roche Diagnostics CoaguChek-PST for prothrombin time Roche Diagnostics 85610QW Roche Diagnostics CoaguChek and CoaguChek S System, PT-S Test Strips (prothrombin time) Roche Diagnostics 85610QW
Protein, Total Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP) Abaxis, Inc 84155QW Abaxis Piccolo xpress Chemistry Analyzer WB (Liver Panel Plus) Abaxis, Inc 84155QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc)(WB) Abaxis, Inc. 84155QW
Cobas RSV Nucleic Acid Test for Use on the cobas Liat System IQUUM, INC 87807QW BD Veritor System for Rapid Detection of RSV Becton Dickinson & Co 87807QW Binax NOW RSV Test (RSV antigen, qual) Binax, Inc. 87807QW Fisher Scientific Sure-Vue RSV Test SA Scientific, Inc. 87807QW Integrated Biotechnology Quick Lab RSV Test (direct antigen, qualitative) Integrated Biotechnology, Corp 87807QW
Meridian Biosci. Immunocard Stat! RSV Plus Meridian Bioscience, Inc. 87807QW
DOH 681-018 April 2017 Page 42 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Quidel Quick Vue RSV Test Quidel Corp 87807QW Rapid Response RSV Test Sa Scientific Inc 87807QW Remel Xpect RSV SA Scientific, Inc. 87807QW SA Scientific SAS RSV Alert SA Scientific, Inc. 87807QW SA Scientific SAS RSV Test SA Scientific, Inc. 87807QW Sofia RSV Quidel Corporation 87807QW Wampole Laboratories Clearview Integrated Biotechnology Corp 87807QW
Semen Embryotech Laboratories FertiMARQ Home Diagnostic Screening Test for Male Infertility Embryotech Laboratories, Inc. 89300QW
Fertell Male Fertility Test Genosis, LTD 89321QW Fertility Solutions Semen Analysis Qualitative Fertility Solutions 89300QW SpermCheck Fertility Princeton Biomeditech Corp Pending SpermCheck Vasectomy Princeton Biomeditech Corp 83900QW Trak Male Fertility Testing System Sandstone Diagnostics, Inc Pending
YO Home Sperm Test Medical Electronic Systems, LTD Pending
Strep Antigen Test Abbott Signify Strep A Dipstick Innovacon 87880QW Abbott Signify Strep A Test Wyntek 87880QW Acceava Strep A Twist Rapid Test Innovacon 87880QW Acceava Strep A Test Innovacon 87880QW Accustrip Strep A Princeton Biomeditech Corp 87880QW Acon Strep A Rapid Strip Test Acon 87880QW Acon Strep A Twist Rapid Test Acon 87880QW Alere, Strep A, Alere I Instrument Alere Scarborough, Inc 87880QW Applied Biotech SureStep Strep A (II) Applied Biotech, Inc 87880QW Applied Biotech SureStep Strep A Exact Applied Biotech, Inc 87880QW BD Veritor System for Rapid Detection of Group A Strep Becton Dickinson & Co. 87880QW Beckman Coulter ICON DS Strep A Test Princeton BioMeditech 87880QW Beckman Coulter ICON FX Strep A Test (formerly SmithKline) Binax 87880QW Beckman Coulter Primary Care Diagnostics ICON DS Strep A Test Acon Laboratories 87880QW Beckman Coulter Primary Care Diagnostics ICON SC Strep A Test Acon Laboratories 87880QW Beckman Coulter Primary Care Diagnostics ICON FX Strep A Immunochemical Strep A Antigen Test Beckman Coulter, Inc. 87880QW
Becton Dickinson Chek Group A Strep Test Innovacon, Ind 87880QW Becton Dickinson LINK 2 Strep A Rapid Test Becton Dickinson 87880QW Binax Clearview Advanced Strep A Binax, Inc 87880QW Binax NOW Strep A Test Binax, Inc 87880QW BioStar Acceava Strep A Test BioStar 87880QW Biotechnostix Rapid Response Strep A Rapid Test Devise/Strip Acon Laboratories 87880QW BTNX Rapid Response Strep A Rapid Test Strips Sa Scientific, Inc 87880QW
DOH 681-018 April 2017 Page 43 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Cardinal Health SP Brand Rapid Test Strep A Dipstick / Rapid Test Strep A Cassette Applied Biotech, Inc. 87880QW
Cardinal Health Strep A Cassette and Dipstick-Rapid Test Alere Sd 87880QW Clearview Strep A Exact Dipstick Applied Biotech, Inc. 87880QW CLIA Waived Inc Rapid STREP A Test Sa Scientific Inc 87880QW Consult Diagnostics STREP A Rapid Dipstick Innovacon, Inc 87880QW CTMI Strep A Rapid Test Strip Innovacon, Ind 87880QW DE Healthcare Products, TruView Strep A Test / Strep A Cassette DE Healthcare Products 87880QW Diagnostic Test Group Clarity Strep A Rapid Test Strips Princeton BioMeditech Corp 87880QW Fisher HealthCare Sure-Vue Strep A (direct from throat) Applied Biotech, Inc. 87880QW Genzyme Contrast Strep A Genzyme Diagnostics 87880QW Genzyme OSOM Ultra Strep A Test (25 test kit) Genzyme Diagnostics 87880QW Germaine Laboratories StrepAim Rapid Dipstick Test (Strep Group A) Acon Laboratories, Inc. 87880QW
Germaine Laboratories Strep AIM Tower Acon Laboratories, Inc. 87880QW Henry Schein Inc, OneStep+ Strep A Test / OneStep+ Strep A Dipstick Test / OneStep+ Strep A Cassette Test / OneStep Pro+ Henry Schein, Inc 87880QW
ICON DS Strep A Test ACON Laboratories, Inc. 87880QW IMI Signify Strep A Dipstick Innovacon Inc 87880QW Immunostics Detector Strep A Direct ACON Laboratories, Inc. 87880QW Immunostics Immuno/StrepA Detector ACON Laboratories, Inc. 87880QW Instant Tech iStrep One Step Strep A Test ACON Laboratories, Inc. 87880QW Inverness Med BioStar Acceava Strep A Test ACON Laboratories, Inc. 87880QW Inverness Med BioStar Acceava Strep A Twist Innovacon, Inc 87880QW Inverness Medical Clearview Strep A Exact II Dipstick Innovacon, Inc. 87880QW Inverness Medical Signify Strep A Cassette Innovacon, Inc 87880QW Jant Pharmacal AccuStrip Strep A (II) Jant Pharmacal 87880QW Jant Pharmacal AccuStrip Strep A Value+ Test Strip Innovacon 87880QW Jant Pharmacal Accutest Integrated Strep A Rapid Test Device Jant Pharmacal 87880QW Jant Pharmacal Clinipak Strep A Rapid Test Strip Jant Pharmacal 87880QW Laboratory Supply Company (LSC) PEP Strep A Cassette / PEP Strep A Dipstick Test Acon Laboratories Co 87880QW
LABSCO Advantage Strep A Princeton BioMediTech Corp 87880QW Roche Molecular, cobas Liat System IQuum, Inc. 87880QW LifeSign LLC Status Strep A Princeton BioMediTech Corp 87880QW Mainline Confirms Strep A Dots Test Mainline Technology, Inc 87880QW McKesson Consult Diagnostics Strep A Test Dipstick Alere 87880QW McKesson Medi-Lab Performance Strep A Test Dipstick/Cassette Applied Biotech, Inc. 87880QW McKesson Medi-Lab Strep A Test Dipstick Innovacon, Inc. 87880QW McKesson Medi-Lab Strep A Test – Twist Innovacon, Inc. 87880QW McKesson Strep A Test Dipstick/Cassette Applied Biotech, Inc. 87880QW Medline Strep A Test Strips {Throat Swabs} Alere, INC. 87880QW MediLab Performance Strep A Twist Rapid Test MediLab 87880QW Meridian Diag. ImmunoCard STAT Strep A Meridian Diagnostics 87880QW Moore Medical The Supply Experts Strep A Test – Cassette Innovacon, Inc 87880QW Moore Medical The Supply Experts Strep A Rapid Test – Dipstick Innovacon 87880QW Mooremedical Strep A Rapid Test – Dipstick Alere San Diego Inc 87880QW PEP Performance Enhanced Products Strep A Cassette Test / Strep A Dipstick Acon Laboratories 87880QW
PerMaxin Rediscreen Strep A Rapid Test Acon Laboratories 87880QW PerMaxin Rediscreen Strep A Twist Cassette Innovacon 87880QW
DOH 681-018 April 2017 Page 44 of 47
Test Name/Specific Test System Manufacturer Approved
CPT Code(s)
Polymedco, Inc. Poly Stat A (II) for Group A Strep [direct from throat swab] Applied Biotech, Inc. 87880QW
Poly stat Strep A Flip Test Princeton BioMediTech Corp 87880QW Poly stat Strep A Strip Test Princeton Biomeditech Corp 87880QW Polymedco Poly Stat Strep A Dipstick Innovacon 87880QW Polymedco Poly Stat Strep A Liquid Test Polymedco 87880QW Princeton BioMediTech BioStrep A Test Princeton BioMediTech Corp 87880QW Princeton Biomeditech Status First Strep A Princeton BioMediTech Corp 87880QW ProAdvantage by NDC Strep A Test Innovacon 87880QW PSS Consult Diagnostics Strep A Dipstick Innovacon 87880QW PSS World Medical Select Diagnostics Strep A Dipstick Innovacon 87780QW PSS World Medical Select Diagnostics Strep A Twist Innovacon 87780QW Quidel QuickVue Dipstick Strep A Quidel 87880QW Quidel QuickVue In-Line Strep A Quidel 87880QW Quidel QuickVue In-Line One-Step Strep A Quidel 87880QW Quidel Sofia Strep A+ FIA (from throat swab only) Quidel Corp 87880QW RAC Medical Clarity Strep A Twist Rapid Strep Test Device/Strip Acon laboratories, Co 87880QW SMC Direct, LLC, RefuAH Strep A Rapid Wondfo Biotech Co., LTD. 87880QW Remel RIM A.R.C. Strep A Test (direct from throat swab) Applied Biotech, Inc. 87880QW SA Scientific SAS Strep A (direct from throat swab) SA Scientific, Inc. 87880QW Sacks Medical Refuah Strep A Rapid Test Acon Laboratories 87880QW StatusFirst Strep A Princeton BioMeditech Corp 87880QW Select Medical Products Brand Rapid Test Strep A Dipstick Innovacon, Inc 87880QW Sekisui Diag OSOM Strep A Test (direct throat swab) Sekisui Diagnostics 87880QW Sekisui Diag OSOM Ultra Strep A Test Sekisui Diagnostics 87880QW Select Medical Products Brand Rapid Test Strep A Twist Innovacon, Inc 87880QW Signify Strep A Dipstick Applied Biotech, Inc. 87880QW SmithKline ICON Fx Strep A Test (from throat swab only) Binax 87880QW Stanbio Laboratory E-Z Well Strep A Rapid Device Test Acon Laboratories Co 87880QW Stanbio Qustick Strep A Acon Laboratories Co 87880QW StrepAim Princeton Biomeditech Corp 87880QW
Wondofo One Step Strep A Swab Test Guangzhou Wondfo Biotech Co., LTD. 87880QW
Wyntek Diagnostics OSOM Strep A Test Wyntek Diagnostics, Co 87880QW Wyntek Diagnostics OSOM Ultra Strep A Test Wyntek Diagnostics, Co 87880QW
Syphilis Diagnostics Direct LLC Syphilis Health Check (Fingerstick WB Only) Diagnostics Direct LLC 86780QW
Trichomonas Genzyme Osom Trichomonas Rapid Test Genzyme Corp 87808QW Sekisui Diag OSOM Trichomonas Rapid Test Genzyme Corp 87808QW
Triglycerides Abaxis Piccolo xpress Chemistry Analyzer {capillary-finger stick} (Triglyceride) Abaxis, Inc. 84478QW
Chemstrip Mini UA (bilirubin---ketone---protein---urobilinogen---blood--- leukocyte---pH---glucose---nitrite---sp gr) Roche/Boehringer Mannheim 81003QW
Clarity Diagnostics LLC, Clarify U122 Urine Analyzer (bilirubin---ketone---protein---urobilinogen---blood--- leukocytes---pH---glucose---nitrite---sp gr)
ACON Laboratories, INC 81003QW
DOH 681-018 April 2017 Page 46 of 47
Test Name/Specific Test System Manufacturer Approved
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer (bilirubin---ketone--- protein---urobilinogen---blood--- leukocytes--- pH---glucose--- nitrite---sp gr)
Acon Laboratories, Inc 81003QW
Express Diagnostics International, Incorporated UTI Test Strips(leukocyte esterase, nitrite) Teco Diagnostics 81003QW
Express Diagnostics International, Incorporated Urine Reagent Strips 10 for Urinalysis (bilirubin---ketone--- protein---urobilinogen---blood---leukocytes---pH---glucose--- nitrite---sp gr)
Siemens Clinitek Status Connect System (bilirubin---ketone---protein---HCG---blood---leukocytes---pH---glucose---nitrite---sp gr---creatinine---microalbumin)