FDA product code PCN
Immunoglobulin G Kappa Heavy And Light Chain Combined
Immunology·Class 2·21 CFR 866.5510
US regulatory classifications
- US Product Code (FDA)
- PCNView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.5510View CFR Regulation →
- Medical specialty
- Immunology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
Definition
Intended for the in-vitro quantification of IgG kappa concentration in human serum.
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About this record
Immunoglobulin G Kappa Heavy And Light Chain Combined 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.