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U.S. Department of Health and Human Services

Product Classification

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Device igal heavy & light chain combined
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Definition Intended for the in-vitro quantification of iga lambda 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.
Physical State The kit is composed of polyclonal monospecific sheep Anti-IgA Lambda antibody, IgA Lambda Calibrator, 2 IgA Lambda Controls, and IgA Lambda Supplementary Reagent
Technical Method Nephelometric method
Target Area Blood serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOPY
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
Third Party Review Not Third Party Eligible
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