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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device autoantibodies, glutamic acid decarboxylase (gad)
Regulation Description Multiple autoantibodies immunological test system.
Definition The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).
Product CodeNWG
Regulation Number 866.5660
Device Class 2