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Autoantibodies, Nuclear Body Protein, Sp100

FDA product code NUM · 1 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5090
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2005-06-13 – 2005-06-13

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.

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