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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device autoantibodies, nuclear pore glycoprotein gp210
Regulation Description Antimitochondrial antibody immunological test system.
Definition The device is used for the detection, in human serum or plasma, of autoantibodies to gp210 (nuclear pore glycoprotein gp210) as an aid in the diagnosis of primary biliary cirrhosis.
Product CodeNRI
Regulation Number 866.5090
Device Class 2

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