FDA product code PDJ
Hemoglobin A1c Test System
Clinical Chemistry·Class 2·21 CFR 862.1373
US regulatory classifications
- US Product Code (FDA)
- PDJView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 862.1373View 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.
Search keywords
Click to search for similar devices in our global database
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.