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FDA product code OPX

Immunoglobulin A Kappa Heavy & Light Chain Combined

ImmunologyClass 221 CFR 866.5510
Verified
US regulatory classifications
US Product Code (FDA)
OPX
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 iga kappa concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients.

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01IgA Kappa02Immunoglobulin test03Heavy light chain04Kappa light chain05Plasma cell disorder06Multiple myeloma07Diagnostic immunoassay08Antibody test09Protein assay10Immune system test
About this record

Immunoglobulin A Kappa Heavy & 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.