Autoantibodies, Nuclear Pore Glycoprotein Gp210
The Nuclear Pore Glycoprotein Gp210 Autoantibody device is an in vitro diagnostic assay used for the detection of autoantibodies to gp210 in human serum or plasma as an aid in the diagnosis of primary biliary cirrhosis. Elevated gp210 autoantibodies are associated with this autoimmune liver disease. It is an FDA Class 2 device regulated under 21 CFR 866.5090 in the Immunology specialty, with product code NRI, and requires 510(k) clearance. The device is eligible for third-party review. It is not an implant and does not provide life-sustaining support.
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Basic Information
- Product Code
- NRI
- Device Class
- FDA class 2
- Regulation Number
- 866.5090
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.