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U.S. Department of Health and Human Services

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Device immunoglobulin m lambda 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 IgM lambda concentration in human serum. The result is to be used with previously diagnosed IgM Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
Physical State Kit is composed of polyclonal monospecific sheep anti-IgM lambda antibody, IgM lambda Calibrator, 2 IgM lambda Controls, and IgM lambda Supplementary Reagent
Technical Method Nephelometric immunoassay method
Target Area Peripheral human blood, serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodePDF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible