General Chemistry Reagent cobas® Hemoglobin A1c (HbA1c) III CLIA Non-Waived For cobas c Systems 200 Tests

Name: General Chemistry Reagent
Brand: cobas®

REAGENT, A1CX3 COBAS C PACK GRN (200T/EA) D/S

McKesson #

1293332

Manufacturer #

08445699190

Brand

cobas®

Manufacturer

Roche Diagnostics

Country of Origin

Unknown

Application

General Chemistry Reagent

Buy American Act (BAA) Compliant

CLIA Classification

CLIA Non-Waived

CLIA Classified

CLIA Non-Waived

Container Type

Pack

For Use With

For cobas c Systems

Number of Tests

200 Tests

Product Dating

McKesson Acceptable Dating: we will ship >= 90 days

Specialty

General Chemistry

Storage Requirements

Requires Refrigeration

Test Category

HbA1c

Test Method

Tetradecyltrimethylammonium Bromide

Test Name

Hemoglobin A1c (HbA1c) III

Trade Agreement Act (TAA) Compliant

UNSPSC Code

41116004

The Tina-quant Hemoglobin A1cDx Gen.3 assay is intended for use as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes
It is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or venous whole blood on the cobas c 303 and cobas c 503 clinical chemistry analyzers
HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus
Analyzer(s) on which cobas c pack(s) can be used: cobas c 303, cobas c 503