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Autoantibodies, Nuclear Pore Glycoprotein Gp210

FDA product code NRI · 2 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
2004-06-25 – 2006-10-18

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.

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