NUM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Autoantibodies, Nuclear Body Protein, Sp100
- 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 SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| QUANTA LITE SP100 ELISA (K050662) | Inova Diagnostics, Inc. | 2005-06-13 |
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Every clearance here is in the API, with alerts when new ones post.