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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoglobulin g 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 IgG lambda concentration in human serum. The result is to be used with previously diagnosed IgG multiple myeloma, in conjunction with other clinical and laboratory findings.
Product CodePCO
Regulation Number 866.5510
Device Class 2

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