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e-mail:[email protected], http://www.mediconsa.com General Electronic Commercial Registry (G.E.MI.) No. 414401000, Ex Reg. No: 16439/06/Β/88/24 - Company
listed in the Athens Stock Exchange
PRODUCTS FOR EXPORT
2019
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Company profile
Medicon is one of the largest companies in the field of laboratory diagnostics in Greece, and the only Greek in vitro diagnostics manufacturer with our own:
Fully equipped R&D facility.
Production plant for Clinical Chemistry, Hematology and Immunochemistry reagents.
Refurbishment plant.
Production of medical software and process optimization solutions for laboratories.
Chain of diagnostic laboratories.
We sell our branded products to Greek healthcare providers and several export customers and we also export products in bulk to world class IVD companies in a number of countries (Germany, Austria, UK, Italy, Finland, Spain, China, Slovenia, India, Latin America, etc).
Over the years we have developed our own technology and flexibility that allow adapting our products to several types of automated laboratory analyzers and we offer our customers first class services and support.
We have extensive expertise in reagents for Immunoturbidimetric assays (ITA). The performance characteristics of our ITA methods are among the best in the industry and our ITA reagents can be applied on several types of chemistry analyzers, offering fast and economic testing of a large variety of specific proteins.
Our applications lab is equipped with modern types of analyzers from world-class manufacturers and undertakes application of our products on these systems.
We strongly believe in ensuring peace-of-mind to users of our products, so we design our system-specific reagents to perfectly match the individual analyzer type characteristics and workflow, and provide enhanced performance and user friendliness by prolonged on-board and calibration stability and by carefully selected pack sizes that eliminate waste.
By developing refurbishment technology, we have on one hand ensured availability of instruments at very low cost. On the other, we export these systems mainly to the US, where they are accepted as high-value items, due to the excellent work we do to ensure a new, high performance life for these instruments.
We apply a comprehensive Quality Assurance program that ensures high quality, and we have ISO9001 and ISO 13485 accreditation. All our products are CE marked according to the IVDD 98/79/EC, and several products are in the course of FDA submission.
Our ISO 14001:2005 is testament to our consideration and care for minimizing our environmental impact.
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Products list
We manufacture reagents for a large variety of tests listed below, in instrument-specific formats with system barcodes, specially designed for direct placement on analyzers.
Our reagent lines are:
1. Reagents for direct placement on Beckman Coulter (ex-Olympus) AU-series chemistry analyzers.
2. Reagents for direct placement on Siemens ADVIA 1800/2400 series chemistry analyzers. 3. Reagents for direct placement on Mindray BS200/220 E series chemistry analyzers (under
development). 4. Reagents for manual or general purpose use. 5. Bulk reagents for OEM packaging. 6. Calibrators and controls.
Amyloid a, serum Cystatin c κ light chains U-CSF Protein
Antithrombin III D-Dimer λ light chains UIBC
Apo A1 Ethanol Lipase Urea
Apo B Ferritin Lipoprotein (a) Uric acid
ASO Fibrinogen Lysozyme
AST (GOT) G-6PDH Magnesium
Note: The above tests have been fully developed and tested with several analytical platforms, however for each instrument-specific series we are manufacturing and packing ONLY certain tests as follows, for which commercial interest has been expressed. In case you cannot find a specific test of your interest in the lists below, please contact Medicon.
Package inserts and Application sheets are available for download at the following link:
141G-0189 URINARY - CSF PROTEIN PYROGALLOL RED 3x50
Notes:
1. Additional test items in GP packaging may be made available upon request. 2. Sales of these items can only be reserved for customers supplying binding forecasts. 3. Package inserts contain application data for manual use. These products may be used with
automated open-system chemistry analyzers, after individual application protocols are developed and programmed in the analyzer menu. Medicon does not make performance claims for automated use.
4. These kits include standard solutions for calibration, where required. For automated use with open-system chemistry analyzers, our calibrators listed below may also be used for convenience.
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Calibrators and control materials DESCRIPTION CODE FORM VOLUME (mL)
5-NUCLEOTIDASE CONTROL 1478-0505 LYO 2x1
A1 MICROGLOBULIN CAL 1478-0868 LRTU 6x1x1
A1 MICROGLOBULIN CON 1478-0867 LRTU 3x1
ACE CALIBRATOR 1578-1160 LYO 6x1
ACE CONTROL 1578-1165 LYO 2x3x1
ADA CALIBRATOR 1478-0900 LYO 4x1
ADA CONTROL 1478-0905 LYO 2x3x1
ALDOLASE CALIBRATOR 1578-0511 LYO 3x1
ALDOLASE CONTROLS 1578-0512 LYO 2x3x1
AMMONIA CALIBRATOR 1478-1042 LRTU 2x5
AMMONIA CONTROL 1478-1045 LRTU 2x2x5
APO-A1/APO-B CALIBRATOR 1478-0550 LRTU 3x1x1
APO-A1/APO-B CONTROL LEVEL 1 1578-0553 LRTU 3x3
APO-A1/APO-B CONTROL LEVEL 2 1578-0554 LRTU 3x3
ASO CALIBRATOR 1478-1062 LRTU 5x1x1
B-2-MICROGLOBULIN CAL 4X1 1578-0860 LRTU 4x1x1
CK-MB CALIBRATOR 1578-0291 LYO 3x1
CK-MB CONTROL 1578-0295 LYO 2x3x2
CLINICAL CHEMISTRY CONTROL LEVEL 1 1578-0901-12 LYO 12x5
CLINICAL CHEMISTRY CONTROL LEVEL 2 1578-0902-12 LYO 12x5
CRP CALIBRATOR 1478-0522 LRTU 5x1x1
CRP LATEX CALIBRATOR 1478-0529 LRTU 5x1x1
CYSTATIN-C CALIBRATOR 1478-0592 LRTU 6x1x1
CYSTATIN-C CONTROL 1478-0591 LRTU 2x3x2
D-DIMER CALIBRATOR 1478-1182 LYO 5x1x1
D-DIMER CONTROL 1478-1186 LYO 2x2x1
ETHANOL CALIBRATOR 1478-1120 LRTU 2x5
ETHANOL CONTROL 1478-1125 LRTU 2x2x5
FERRITIN CALIBRATOR 1478-0275 LRTU 5x1x1
FERRITIN CONTROL 1478-0276 LRTU 2x2x1
FIBR/PLG CALIBRATOR 1478-1335 LYO 4x1
FIBR/PLG CONTROL 1478-1330 LYO 2x3x1
G6PDH CONTROLS 1578-0910 LYO 3x2x0,5
HbA1c CALIBRATOR 1578-1058 LRTU 1x8 + 5x1x2
HbA1c CONTROL 1578-1057 LYO 2x2x0,25
IGE CALIBRATOR 1478-0800 LRTU 4x1x1
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DESCRIPTION CODE FORM VOLUME (mL)
IMMUNOLOGY CONTROL 1 1578-1195-04 LRTU 4x3
IMMUNOLOGY CONTROL 2 1578-1196-04 LRTU 4x3
IMMUNOLOGY CONTROL 3 1578-1197-04 LRTU 4x3
LACTATE CALIBRATOR 1478-1092 LRTU 3x2
LP(a) CALIBRATOR 1478-0530 LRTU 6x1
LP(a) CONTROL HIGH 1478-0532 LRTU 6x1
LP(a) CONTROL LOW 1478-0531 LRTU 6x1
MALB/UPROT CONTROL 1478-0188 LRTU 2x3x3
MEDI-CAL CHEMISTRY CALIBRATOR 1578-0891 LYO 12x5
MICROALBUMIN CALIBRATOR 1578-0852 LRTU 5x1x1
PROTEIN STANDARD 1578-1190 LRTU 5x1x1
RF CALIBRATOR 1478-1030 LRTU 5x1x1
sTfR CALIBRATOR 1478-0749 LYO 6x1x1
sTfR CONTROL 1478-0748 LYO 2x3x1
Notes:
1. LYO indicates freeze-dried materials, to give the indicated volume after
reconstitution. LRTU indicates materials liquid, ready to use.
2. Calibration materials have assigned values traceable to International Reference
Materials, where available, or according to Medicon master lot materials.
3. Medicon Calibrators and Control materials are for use with all our reagent lines, so
assigned values are indicated for each instrument line.
4. For constituents and assigned values please refer to https://medicondoc.com
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Bulk reagents for OEM packaging
Our reagents are available for export in bulk form, for further OEM processing. Bulk products are shipped as “Raw materials for further processing”, not as In vitro diagnostic reagents for testing human samples.
Packaging materials: 1Lt Nalgene® and/or COEX® bottles, 20Lt and 5Lt Qubitainer® pouches, optionally customer vials. All packaging materials are certified for use with clinical chemistry reagents.
Bulk reagents may be of our standard production, or according to the specific performance requirements of the buyer, as set under special agreement.
Before batch release, bulk reagents are tested for quality and performance against specifications under the same rigorous protocol used for our own branded reagents. QC results for each batch will be made available to the buyer, as obtained by testing on certain types of automated discrete chemistry analyzers, solely according to our own internal QC procedures for release of products. We will also provide testing data for regulatory purposes, however all final packaging, QC, certification, registration, and marketing actions will be the responsibility of the buyer.
MSDS documents will be provided for each item upon request.
Packaging and/or specifications may change without previous notice.
For further information please contact the Exports department at