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Hemoglobin A1c Test System

FDA product code PDJ · 19 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1373
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2013-08-08 – 2026-01-06

Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.

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