Affordable, Accurate, Accessible Diagnostics for All. Located in Cochin, Kerala State, ubio is one of the leading manufacturer of in vitro diagnostics devices in India. From its inception in the year 2008 as an Assay Development company, ubio has grown up into a full-fledged IVD manufacturer contributing largely to the human and animal health sector. The products are manufactured under ISO 13485 certified Quality Management System, in its state of the art GMP certified manufacturing facility. ubio’s new manufacturing facility commissioned in 2014, has the capacity to manufacture 200000 rapid test devices per day. This fully automated facility consists of CLASS 10000 assembly suits, under <10% RH, Automated coating, Lamination and assembly lines, Fully automated ELISA manufacturing Line, SPCE based Biosensor lines, CLASS 10000 Sterile Buffer filling facility with fully automated vial and bottle filling lines, Biosafety III culture room, cold rooms, fully equipped Quality control laboratory and R&D laboratories for Assay development, Molecular Biology and Bioengineering. HUMAN and ANIMAL HEALTH DIAGNOSTICS CONTRACT ASSAY DEVELOPMENT Low turnaround time Validated Technology platforms, Product development using technologies already commercialised by ubio. Stable Products and flexibility in optimisation. Clinical validation in actual samples. 100% confidentiality. Scaling up and pilot manufacturing facility Option for further contract manufacture Full Technology Transfer Continuous support from ubio Team. Sales and other business enquiries : +91-9562307770 Support on orders, shipments and billing : +91-9562207770 Contract Assay Development : +91 9744122269 Quality Assurance and Complaints : +91 9744022260 UBIO BIOTECHNOLOGY SYSTEMS PVT. LTD #15A, BIOTECHNOLOGY ZONE, KINFRA HITECH PARK, KALAMASSERY, COCHIN, KERALA, INDIA-683503 WEB: WWW.UBIO.IN EMAIL: CONTACT@UBIO.IN RAPID HUMAN DIAGNOSTICS RAPID VETERINARY DIAGNOSTICS CONTRACT MANUFACTURE ubio is the right manufacturing partner for you, especially if you need: Variable-volume manufacture Quick introduction of new product into the market without initial capital investment Protection for your investment against market fluctuations, obsolescence, and competition Quick scale-up to peak demand without capital investment Product List 2014 Distributed By:
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Affordable, Accurate, Accessible Diagnostics for All.
Located in Cochin, Kerala State, ubio is one
of the leading manufacturer of in vitro
diagnostics devices in India. From its
inception in the year 2008 as an Assay
Development company, ubio has grown up
into a full-fledged IVD manufacturer
contributing largely to the human and
animal health sector. The products are
manufactured under ISO 13485 certified
Quality Management System, in its state
of the art GMP certified manufacturing
facility.
ubio’s new manufacturing facility
commissioned in 2014, has the capacity to
manufacture 200000 rapid test devices per
day. This fully automated facility consists
of CLASS 10000 assembly suits, under <10%
RH, Automated coating, Lamination and
assembly lines, Fully automated ELISA
manufacturing Line, SPCE based Biosensor
lines, CLASS 10000 Sterile Buffer filling
facility with fully automated vial and bottle
filling lines, Biosafety III culture room, cold
rooms, fully equipped Quality control
laboratory and R&D laboratories for Assay
development, Molecular Biology and
Bioengineering.
HUMAN and ANIMAL HEALTH DIAGNOSTICS
CONTRACT ASSAY DEVELOPMENT
Low turnaround time
Validated Technology platforms,
Product development using
technologies already
commercialised by ubio.
Stable Products and flexibility in
optimisation.
Clinical validation in actual
samples.
100% confidentiality.
Scaling up and pilot
manufacturing facility
Option for further contract
manufacture
Full Technology Transfer
Continuous support from ubio
Team.
Sales and other business enquiries : +91-9562307770
Support on orders, shipments and billing : +91-9562207770
Contract Assay Development : +91 9744122269
Quality Assurance and Complaints : +91 9744022260
UBIO BIOTECHNOLOGY SYSTEMS PVT. LTD #15A, BIOTECHNOLOGY ZONE,
Filariasis Antibody Test Lateral flow Immunoassay for anti Wuchereria bancrofti and Brugia malayi
antibodies in human blood, serum or plasma.
Leishmaniasis Antibody Tests One step Immuno qualitative detection of antibodies to members of L. donovani complex in human serum, plasma or whole blood.
Leishmaniasis Ab rK39 test This test uses rK39 antigen, and it is recommended for all geographies except East Africa.
Leishmaniasis Ab rK28 test This test uses rK28 antigen, and it is recommended for use in East African countries.
Brucella IgG Lateral flow assay for detection of IgG response of Brucella abortus, Brucella melitensis and brucella suis infection in human.
Leptospira IgM IgM lateral flow assay for Human Leptospirosis. The test is able to detect all serovars of Leptospira that causes leptospirosis in humans.
Typhoid Rapid Tests Lateral flow assays for detection of IgM and IgG antibodies specific to Salmonella enterica serovar Typhi (Salmonella Typhi) in human blood, serum or plasma. The tests use a cocktail of purified Salmonella Typhi H and O antigens. The following tests are available.
Typhoid IgG (Serum or Whole Blood)
Typhoid IgM (Serum or Whole Blood)
Typhoid IgG/IgM (Serum or Whole Blood)
Typhoid-Brucella Combo test Dengue Rapid Tests These tests detect IgG, IgM and NS1 antigens of all known four serotypes
Malaria Pv LDH Antigen test Malaria Antibody Test One step immuno-chromatographic assay for detection of Pv/Pf MSP and CSP specific antibodies of all isotypes (IgA, IgG and IgM) in Human blood, serum or Plasma
ENTERIC INFECTIONS
Rota-Adeno Antigen test Rapid immuno-chromatographic assay for detection of Rota and Adeno
virus antigens in human stool in acute gastro enteritis cases.
H Pylori Antibody H.pylori test is a rapid test for the qualitative detection of antibodies of all isotypes (IgG, IgM, IgA, etc.) specific to Helicobacter pylori in human serum, plasma or whole blood
H Pylori Antigen Test H.pylori Ag test is a rapid test for the qualitative detection of Helicobacter pylori antigen in human fecal specimen.
CONTRACT MANUFACTURING PRODUCTS
The following products are available for contract manufacturing only.
C-Reactive Protein(CRP)
Thyroid Stimulating Hormone (TSH)
HIV ½ Antibody
HBsAg
HCV Antibody
HBV Ab
Syphilis
Drug of Abuse THC, TCA, K2, PCP, PPX, Oxycodone, Methadone, Morphine, MDMA, Ketamine, Methamphetamine, Barbital, Benzodiazepine, Amphetamine,
Cancer Markers PSA, CEA, AFP and CA 125
HUMAN TB ANTIGEN TESTS
MPT 64 Antigen test One step Immuno-chromatographic assy for the detection of MPT 64 Tb antigen in culture fluids and solid cultures.
TB LAM Test Mycobacterium tuberculosis and bovis specific Lipoarabinomannan antigen detection test for culture fluids. (also can be used for sputum testing)
FERTILITY HORMONES
LH test Home ovulation test for detection of Luteinising Hormone in human urine.(25mIU/ml)
hCG Home urine pregnancy test for detection of human chorionic Gonadotropins in Human urine. (10mIU/ml). Available as Card and Strips
Contract manufacturing services under OEM branding
and loan license are available.
Tests are available in default pack size of 30 tests.
Customs pack sizes also available on request.
Products are available as uncut sheets also.
HUMAN DIAGNOSTICS
UBIO BIOTECHNOLOGY SYSTEMS PVT. LTD #15A, BIOTECHNOLOGY ZONE, KINFRA HITECH PARK, KALAMASSERY,COCHIN, KERALA, INDIA-683503, WEB: WWW.UBIO.IN, EMAIL: [email protected]