NRI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Autoantibodies, Nuclear Pore Glycoprotein Gp210
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5090
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| QUANTA LITE PBC SCREEN IGG/IGA ELISA (K061842) | Inova Diagnostics, Inc. | 2006-10-18 | + Add |
| QUANTA LITE GP210 ELISA (K040885) | Inova Diagnostics, Inc. | 2004-06-25 | + Add |
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