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FDA product code PCN

Immunoglobulin G Kappa Heavy And Light Chain Combined

ImmunologyClass 221 CFR 866.5510
Verified
US regulatory classifications
US Product Code (FDA)
PCN
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.5510
View 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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01IgG Kappa02Immunoglobulin test03Kappa chain04Heavy chain05Light chain06Myeloma test07B cell test08Immune marker09Protein marker10Serum protein
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.