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U.S. Department of Health and Human Services

Product Classification

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Device immunoglobulin g kappa heavy and light chain combined
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Definition Intended for the in-vitro quantification of IgG kappa concentration in human serum.
Physical State Kit is composed of polyclonal monospecific sheep anti-IgG kappa antibody, IgG kappa Calibrator, 2 IgG kappa Controls, and IgG kappa Supplementary Reagen
Technical Method Nephelometric immunoassay method
Target Area Blood serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodePCN
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons