NRI — Autoantibodies, Nuclear Pore Glycoprotein Gp210 Class II
FDA product code NRI covers "Autoantibodies, Nuclear Pore Glycoprotein Gp210", a Class II medical device regulated under 21 CFR 866.5090. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NRI
- Device Class
- Class II
- Regulation Number
- 866.5090
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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.