FDA product code DDF
Prothrombin, Antigen, Antiserum, Control
Immunology·Class 1·21 CFR 866.5735
US regulatory classifications
- US Product Code (FDA)
- DDFView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 866.5735View CFR Regulation →
- Medical specialty
- Immunology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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About this record
Prothrombin, Antigen, Antiserum, Control is a medical device type in the Immunology 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.