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Showing 1 — 30 of 30 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 Urinalysis Urine Collection and Preservation Tube, 10ml conical PP vial, clear cap w/gasket, Boric acid preservative.
466-04-06-5A
500/case
n/a
Code 466-04-06-5A
Kit 500/case
Disease n/a
Intended Use

Urine for urinalysis, culture and Special chemistry can be placed into the NCS Urine Collection and Preservation Tube containing a preservative, which allows specimens to be transported without the need for refrigeration. This product is for in vitro use only.

Technology

n/a

Determinations

500/case

Application

n/a

Registrations

Canada Cleared, FDA Cleared, CE not Cleared

Documents

IFU Documents

EN

SDS Documents

Available Upon Request

NCS Urinalysis Urine Collection and Preservation Tube, 10ml conical PP vial, clear cap w/gasket, Tartaric acid preservative.
466-124-04-3
500/case
n/a
Code 466-124-04-3
Kit 500/case
Disease n/a
Intended Use

Urine for urinalysis, culture and Special chemistry can be placed into the NCS Urine Collection and Preservation Tube containing a preservative, which allows specimens to be transported without the need for refrigeration. This product is for in vitro use only.

Technology

n/a

Determinations

500/case

Application

n/a

Registrations

Canada Cleared, FDA Cleared, CE not Cleared

Documents

IFU Documents

EN

SDS Documents

Available Upon Request

NCS Sickle Cell Reagent Test Kit
NCS-020P
20 tests
sickle cell disease
Code NCS-020P
Kit 20 tests
Disease sickle cell disease
Intended Use

For the qualitative detection of hemoglobin (Hb) S in blood using the phosphate solubility method.

Technology

phosphate solubility method

Determinations

20 tests

Application

sickle cell disease

Registrations

Canada Cleared, Not FDA Cleared, Not CE Cleared

Documents

IFU Documents

EN_FR

SDS Documents

Available Upon Request

NCS Sickle Cell Reagent Test Kit
NCS250
250 Tests
sickle cell disease
Code NCS250
Kit 250 Tests
Disease sickle cell disease
Intended Use

For the qualitative detection of hemoglobin (Hb) S in blood using the phosphate solubility method.

Technology

phosphate solubility method

Determinations

250 Tests

Application

sickle cell disease

Registrations

Canada Cleared, Not FDA Cleared, Not CE Cleared

Documents

IFU Documents

EN_FR

SDS Documents

Available Upon Request

NCS Sickle Cell Reagent Test Kit
NCS100
100 Tests
sickle cell disease
Code NCS100
Kit 100 Tests
Disease sickle cell disease
Intended Use

For the qualitative detection of hemoglobin (Hb) S in blood using the phosphate solubility method.

Technology

phosphate solubility method

Determinations

100 Tests

Application

sickle cell disease

Registrations

Canada Cleared, Not FDA Cleared, Not CE Cleared

Documents

IFU Documents

EN_FR

SDS Documents

Available Upon Request

NCS Sickle Controls (Set) 2xpos.2x
NCS-1
Two vials of A/S heterozygous POSITIVE CONTROL, 0.5ML (NCS-1P) Two vials of A/A homozygous NEGATIVE CONTROL, 0.5ML (NCS-1N) Two vials of DILUENT, 1.5 ml-deionized water (NCS-1D)
sickle cell disease
Code NCS-1
Kit Two vials of A/S heterozygous POSITIVE CONTROL, 0.5ML (NCS-1P) Two vials of A/A homozygous NEGATIVE CONTROL, 0.5ML (NCS-1N) Two vials of DILUENT, 1.5 ml-deionized water (NCS-1D)
Disease sickle cell disease
Intended Use

For use as positive and negative controls in testing for the presence or absence of hemoglobin S (HbS) in the sickle cell solubility test or other sickle cell solubility (tube) tests.

Technology

phosphate solubility method

Determinations

Two vials of A/S heterozygous POSITIVE CONTROL, 0.5ML (NCS-1P) Two vials of A/A homozygous NEGATIVE CONTROL, 0.5ML (NCS-1N) Two vials of DILUENT, 1.5 ml-deionized water (NCS-1D)

Application

sickle cell disease

Registrations

Canada Cleared, Not FDA Cleared, Not CE Cleared

Documents

IFU Documents

NCS-1_Rev

SDS Documents

Available Upon Request

Column, Premier 4000 Injections
09-06-4000
4000 Tests
Diabetes Mellitus
Code 09-06-4000
Kit 4000 Tests
Disease Diabetes Mellitus
Intended Use

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

Benefits
Determinations

4000 Tests

Application

Hemoglobinopathies

Registrations

FDA Cleared

CE Marked

Documents
Column, Premier 2500 Injections
09-60-2500
2500 Tests
Diabetes Mellitus
Code 09-60-2500
Kit 2500 Tests
Disease Diabetes Mellitus
Intended Use

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

Benefits
Determinations

2500 Tests

Application

Hemoglobinopathies

Registrations

FDA Cleared

CE Marked

Documents
Premier Resolution A2+F Control Kit
01-04-0045
2 x 300uL
Hemoglobinopathies
Code 01-04-0045
Kit 2 x 300uL
Disease Hemoglobinopathies
Intended Use

Reagents/analytical componets intended for use with the Premier Resolution

Benefits
Determinations

2 x 300uL

Application

Hemoglobinopathies

Registrations

FDA: Cleared

CE Marked

Documents

IFU Documents

Rev O Version

 

Premier Resolution A2+F Calibrator Kit
01-04-0044
2 x 300uL
Hemoglobinopathies
Code 01-04-0044
Kit 2 x 300uL
Disease Hemoglobinopathies
Intended Use

Reagents/analytical componets intended for use with the Premier Resolution

Benefits
Determinations

2 x 300uL

Application

Hemoglobinopathies

Registrations

FDA: Cleared

CE Marked

Documents

IFU Documents

Rev N Version

 

Premier Resolution FASC Position Marker Kit
01-04-0046
2 x 1000uL
Hemoglobinopathies
Code 01-04-0046
Kit 2 x 1000uL
Disease Hemoglobinopathies
Intended Use

Reagents/analytical componets intended for use with the Premier Resolution

Benefits
Determinations

2 x 1000uL

Application

Hemoglobinopathies

Registrations

FDA: Cleared

CE Marked

Documents

IFU Documents

Rev O Version

 

Premier Resolution Piston Wash Reagent (940mL)
01-03-0093
940mL
Hemoglobinopathies
Code 01-03-0093
Kit 940mL
Disease Hemoglobinopathies
Intended Use

Reagents/analytical componets intended for use with the Premier Resolution

Benefits
Premier Resolution Wash Reagent (940mL)
01-03-0088
940mL
Hemoglobinopathies
Code 01-03-0088
Kit 940mL
Disease Hemoglobinopathies
Intended Use

Reagents/analytical componets intended for use with the Premier Resolution

Benefits
Premier Resolution Diluent Reagent (3.8L)
01-03-0087
3.8L
Hemoglobinopathies
Code 01-03-0087
Kit 3.8L
Disease Hemoglobinopathies
Intended Use

Reagents/analytical componets intended for use with the Premier Resolution

Benefits
Premier Resolution Mobile Phase 2 Reagent (3.8L, 940mL)
01-03-0085, 01-03-0083
3.8L, 940mL
Hemoglobinopathies
Code 01-03-0085, 01-03-0083
Kit 3.8L, 940mL
Disease Hemoglobinopathies
Intended Use

Reagents/analytical componets intended for use with the Premier Resolution

Benefits
Premier Resolution Mobile Phase 1 Reagent (3.8L, 940mL)
01-03-0084, 01-03-0082
3.8L, 940mL
Hemoglobinopathies
Code 01-03-0084, 01-03-0082
Kit 3.8L, 940mL
Disease Hemoglobinopathies
Intended Use

Reagents/analytical componets intended for use with the Premier Resolution

Benefits
Premier Resolution Analytical Column
10-06-0006
Each
Hemoglobinopathies
Code 10-06-0006
Kit Each
Disease Hemoglobinopathies
Intended Use

Reagents/analytical componets intended for use with the Premier Resolution

Benefits
Determinations

Each

Application

Hemoglobinopathies

Registrations

FDA: Cleared

CE Marked

Documents

IFU Documents

Rev G Version

 

 

Premier Resolution Analyzer
10-00-0001
Each
Hemoglobinopathies
Code 10-00-0001
Kit Each
Disease Hemoglobinopathies
Intended Use

The Premier Resolution System is an automated High Performance Liquid Chromatography (HPLC) system which performs the separation of hemoglobin species in venous whole blood samples for the quantitative analysis of normal hemoglobin (A, A2, and F), and the qualitative detection of major variant hemoglobin S, C, D-Los Angeles, and E in adult, adolescent, children and infant populations. The assays are performed on venous whole blood samples collected in tubes containing K2EDTA as anticoagulant.
The Premier Resolution System is intended for Professional Laboratory Use only.
The Premier Resolution System is intended for use with analytical components and reagents provided by Trinity Biotech.
The Premier Resolution System is intended to be used in conjunction with other laboratory and clinical findings.
For In Vitro Diagnostic Use.

Benefits
Determinations

Each

Application

Hemoglobinopathies

Registrations

FDA: Cleared

CE Marked

 

Documents

IFU

Column, Premier 500 Injections
09-06-0050
500 Tests
Diabetes Mellitus
Code 09-06-0050
Kit 500 Tests
Disease Diabetes Mellitus
Intended Use

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

Benefits
Determinations

500 Tests

Application

Diabetes Mellitus

Registrations

FDA: Cleared

CE Marked

 

Documents

IFU Documents

REV I Version

 

Column, Premier 1000 Injections
09-06-0046
1000 Tests
Diabetes Mellitus
Code 09-06-0046
Kit 1000 Tests
Disease Diabetes Mellitus
Intended Use

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

Benefits
Determinations

1000 Tests

Application

Diabetes Mellitus

Registrations

FDA: Cleared

CE Marked

Documents

IFU Documents

Rev I Version

 

Premier HbA1c (GHb) Control Kit, 500uL
01-04-0020
2 x 500uL
Diabetes Mellitus
Code 01-04-0020
Kit 2 x 500uL
Disease Diabetes Mellitus
Intended Use

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

Benefits
Determinations

2 x 500uL

Application

Diabetes Mellitus

Registrations

FDA: Cleared

CE Marked

Documents

IFU Documents

Rev H Version

 

 

Premier HbA1c (GHb) Calibrator Kit, 500uL
01-04-0022
2 x 500uL
Diabetes Mellitus
Code 01-04-0022
Kit 2 x 500uL
Disease Diabetes Mellitus
Intended Use

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

Benefits
Determinations

1 x 500uL

Application

Diabetes Mellitus

Registrations

FDA: Cleared

CE Marked

 

Documents

IFU Documents

RevH Version

 

Premier Wash Reagent (940mL)
01-03-0098
940mL
Diabetes Mellitus
Code 01-03-0098
Kit 940mL
Disease Diabetes Mellitus
Intended Use

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

Premier Diluent Reagent (3.8L)
01-03-0097
3.8L
Diabetes Mellitus
Code 01-03-0097
Kit 3.8L
Disease Diabetes Mellitus
Intended Use

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

Premier Buffer A Plus Reagent (3.8L, 940mL)
01-03-0055, 01-03-0058
3.8L, 940mL
Diabetes Mellitus
Code 01-03-0055, 01-03-0058
Kit 3.8L, 940mL
Disease Diabetes Mellitus
Intended Use

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

Benefits
Premier Buffer B Reagent (3.8L, 940mL)
01-03-0081, 01-03-0096
3.8L, 940mL
Diabetes Mellitus
Code 01-03-0081, 01-03-0096
Kit 3.8L, 940mL
Disease Diabetes Mellitus
Intended Use

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

Premier Hb9210™ Analyzer
09-00-0001
Each
Diabetes Mellitus
Code 09-00-0001
Kit Each
Disease Diabetes Mellitus
Intended Use

The Premier Hb9210 System is intended for the quantitative measurement of hemoglobin A1c (HbA1C) in human capillary adn venous WB. HbA1C is used for the monitoring of long-term glucemic control in individuals with Diabetes Mellitus. For in vitro diagnositc use only.

Benefits
Determinations

Each

Application

Diabetes Mellitus

Registrations

FDA: Cleared

CE Marked

 

Documents

IFU Documents

EN Version

 

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Trillergasse 8, 1210 Wien, Dublin
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Trillergasse 8, 1210 Wien, cork
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Shuttleworthstraße 25, 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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Neudorfergasse 1, 1210 Wien, cork
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Divischgasse 4, 1210 Wien, cork
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demo3 Biomedica Medizinprodukte GmbH
Divischgasse 4, 1210 Wien, Dublin
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demo2 Biomedica Medizinprodukte GmbH
Divischgasse 4, 1210 Wien, cork
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test17 Biomedica Medizinprodukte GmbH 4
Scottgasse 8, 1210 Wien, cork
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test13 Biomedica Medizinprodukte GmbH 3
Trillergasse 8, 1210 Wien, cork
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demo9 Biomedica Medizinprodukte GmbH 2
Shuttleworthstraße 25, 1210 Wien, Dublin
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demo5 Biomedica Medizinprodukte GmbH 1
Neudorfergasse 1, 1210 Wien, Dublin
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demo1 Biomedica Medizinprodukte GmbH
Divischgasse 4, 1210 Wien, cork