NUM — Autoantibodies, Nuclear Body Protein, Sp100 Class II
FDA product code NUM covers "Autoantibodies, Nuclear Body Protein, Sp100", a Class II medical device regulated under 21 CFR 866.5090. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NUM
- 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 SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050662 | inova diagnostics | QUANTA LITE SP100 ELISA | June 13, 2005 |