Autoantibodies, Nuclear Pore Glycoprotein Gp210
Device Code: 3068
Product Code(s):
NRI 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.
Device Classification Information
| Device Type ID | 3068 |
| Device Name | Autoantibodies, Nuclear Pore Glycoprotein Gp210 |
| Regulation Description | Antimitochondrial Antibody Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5090 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NRI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3068 |
| Device | Autoantibodies, Nuclear Pore Glycoprotein Gp210 |
| Product Code | NRI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antimitochondrial Antibody Immunological Test System. |
| CFR Regulation Number | 866.5090 [🔎] |
TPLC Last Update: 2019-04-02 20:23:21