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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device autoantibodies, nuclear body protein, sp100
Regulation Description Antimitochondrial antibody immunological test system.
Definition THE DEVICE IS USED FOR THE DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.
Product CodeNUM
Regulation Number 866.5090
Device Class 2

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