CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
July 2013—Abbott announced CE Marking for its Architect clinical chemistry hemoglobin A1c (HbA1c) test, which may aid physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes.
The Architect clinical chemistry HbA1c test is available in Europe, Asia, Latin America, Canada, and Africa, pending country registration. Abbott recently filed for 510(k) clearance with the FDA.
The assay is used in clinical laboratories for the quantitative in vitro measurement of the percent hemoglobin A1c or HbA1c fraction in human whole blood and hemolysate on the Architect c8000 and c4000 systems.
Abbott, 847-937-6100