Pure Global AI
FDA product code PDJ

Hemoglobin A1c Test System

Clinical ChemistryClass 221 CFR 862.1373
Verified
US regulatory classifications
US Product Code (FDA)
PDJ
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.1373
View CFR Regulation
Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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

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01Hemoglobin A1c02HbA1c test03Diabetes test04Glycated hemoglobin05Blood glucose06Diabetic monitor07A1c analyzer08Glucose test09Point of care10Diagnostic system
About this record

Hemoglobin A1c Test System is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.