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Showing 1 — 10 of 264 results
Product Name
Code
Kit
Disease
Premier HbA1c (GHb) Calibrator Kit, 400uL
01-04-0018
2 x 400uL
Diabetes Mellitus
Code 01-04-0018
Kit 2 x 400uL
Disease Diabetes Mellitus
Intended Use

Reagents/analytical componets intended for use with the Premier Hb9210.

Benefits
Determinations

2 x 400uL

Application

Diabetes Mellitus

Registrations

FDA: Cleared

CE Marked

 

Documents

IFU Documents

Rev N Version

 

Premier HbA1c (GHb) Control Kit, 400uL
01-04-0015
2 x 400uL
Diabetes Mellitus
Code 01-04-0015
Kit 2 x 400uL
Disease Diabetes Mellitus
Intended Use

Reagents/analytical componets intended for use with the Premier Hb9210.

Benefits
Determinations

2 x 400uL

Application

Diabetes Mellitus

Registrations

FDA: Cleared

CE Marked

Documents

IFU Documents

Rev O Version

 

 

Premier Buffer A Reagent (3.8L, 940mL)
01-03-0080, 01-03-0095
3.8L, 940mL
Diabetes Mellitus
Code 01-03-0080, 01-03-0095
Kit 3.8L, 940mL
Disease Diabetes Mellitus
Intended Use

Reagents/analytical componets intended for use with the Premier Hb9210.

NCS One Step Multi-Line Screen Test Device (Urine)
NCS-12MOX
25 tests
Qualitative detection of multiple drugs and drug metabolites in human urine.
Code NCS-12MOX
Kit 25 tests
Disease Qualitative detection of multiple drugs and drug metabolites in human urine.
Intended Use

A rapid one step test device for testing combinations of the following drugs: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Oxycodone, Phencyclidine, and Tricyclic Antidepressant.

This test will detect other related compounds, please refer to the Analytical Specificity table in the package insert. This assay provides only a preliminary analytical test result. Gas chromatography/ mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Technology

Rapid immunoassay

Determinations

25 tests

Application

Qualitative detection of multiple drugs and drug metabolites in human urine.

Registrations

Canada Cleared, Not FDA Cleared, Not CE Cleared

Documents

IFU Documents

NCS12MOX ENFR

SDS Documents

Available Upon Request

Captia™ HSV 2 IgM
2325560/2325561
96 Tests/480 Tests
Herpes Simplex Virus (HSV) 2
Code 2325560/2325561
Kit 96 Tests/480 Tests
Disease Herpes Simplex Virus (HSV) 2
Intended Use

The Trinity Biotech Captia™ Herpes Simplex Virus type 2 (HSV 2) IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the in vitro semi-quantitative determination of IgM antibodies in human serum to Herpes simplex type 2 virus and as an aid in the diagnosis of herpes related diseases. High complexity test.

Benefits
Technology
ELISA
Determinations

96 Tests/480 Tests

Application

Infectious Diseases, Virology, Sexual Health, ToRCH

Registrations

FDA: Not Cleared
Canada: Not Cleared
CE: Marked

Captia™ EBV VCA IgG
2325700
96 Tests
Epstein-Barr Virus/Infectious Mononucleosis
Code 2325700
Kit 96 Tests
Disease Epstein-Barr Virus/Infectious Mononucleosis
Intended Use

The Trinity Biotech Captia™ Epstein-Barr Virus Capsid Antigen (EBV VCA) IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative determination of IgG antibodies to Epstein-Barr virus in human serum. The Trinity Biotech anti-EBV VCA IgG assay may be used in conjunction with other Epstein-Barr serologies as an aid in the diagnosis of infectious mononucleosis in the adult population. For in vitro diagnostic use. High complexity test.

Benefits
Technology
ELISA
Determinations

96 Tests

Application

Infectious Diseases, Virology

Registrations

FDA: Cleared
Canada: Not Cleared
CE: Marked

Captia™ CMV IgM 2-Plate
2325250
96 Tests
Cytomegalovirus (CMV)
Code 2325250
Kit 96 Tests
Disease Cytomegalovirus (CMV)
Intended Use

The Trinity Biotech Captia™ Cytomegalovirus (CMV) IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of IgM antibody to cytomegalovirus in human serum. For in vitro diagnostic use. High complexity test.

Benefits
Technology
ELISA
Determinations

96 Tests

Application

Infectious Diseases, Virology, ToRCH

Registrations

FDA: Cleared
Canada: Cleared
CE: Not Marked

Documents

IFU Documents

EN Version

 

SDS Documents

EU EN (CLP) Version

HU (CLP) Version

 

 

Captia™ Measles IgM 2-Plate
2326050
96 Tests
Measles
Code 2326050
Kit 96 Tests
Disease Measles
Intended Use

The Trinity Biotech Captia™ Measles IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the in vitro determination of Measles IgM antibodies in human serum. For in vitro diagnostic use. High complexity test.

Determinations

96 Tests

Application

Infectious Disease, Virology, MMRV

Technology

ELISA

Registrations

FDA: Not Cleared
Canada: Not Cleared
CE: Marked

Documents
Captia™ Mumps IgM 2-Plate
2325950
96 Tests
Mumps
Code 2325950
Kit 96 Tests
Disease Mumps
Intended Use

The Trinity Biotech Captia™ Mumps IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of IgM antibodies in human serum to Mumps for the determination of immunological experience. High complexity test.

Determinations

96 Tests

Application

Infectious Disease, MMRV, Virology

Technology

ELISA

Registrations

FDA: Not Cleared
Canada: Not Cleared
CE: Marked

ImmuGlo™ anti-nDNA Antibody IFA Kit Mouse Kidney/Stomach IFA Kit
1106
48 Tests
Systematic Lupus Erythematosus (SLE)
Code 1106
Kit 48 Tests
Disease Systematic Lupus Erythematosus (SLE)
Intended Use

This device is intended for an indirect immunofluorescence antibody test for the detection and quantitation of antibodies to native (double stranded) deoxyribonucleic acid (nDNA) in human serum

Technology

IFA

Determinations

48

Application

Systemic Lupus Erthematosus (SLE)

Registrations

FDA: Cleared

CE:Marked

Canada: Cleared

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Trillergasse 8, 1210 Wien, Dublin
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Scottgasse 8, 1210 Wien, Dublin
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Trillergasse 8, 1210 Wien, Dublin
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Shuttleworthstraße 25, 1210 Wien, cork
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Shuttleworthstraße 25, 1210 Wien, Dublin
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Neudorfergasse 1, 1210 Wien, cork
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Neudorfergasse 1, 1210 Wien, Dublin
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Divischgasse 4, 1210 Wien, cork
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Scottgasse 8, 1210 Wien, cork
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Trillergasse 8, 1210 Wien, cork
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demo9 Biomedica Medizinprodukte GmbH 2
Shuttleworthstraße 25, 1210 Wien, Dublin
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Neudorfergasse 1, 1210 Wien, Dublin
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demo1 Biomedica Medizinprodukte GmbH
Divischgasse 4, 1210 Wien, cork