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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeOPY
Regulation Number 866.5510
Device Class 2

Device Problems
Incorrect or inadequate test results 1
Low test results 1
Total Device Problems 2

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