Autoantibodies, Nuclear Body Protein, Sp100
Device Code: 3073
Product Code(s):
NUM 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.
Device Classification Information
| Device Type ID | 3073 |
| Device Name | Autoantibodies, Nuclear Body Protein, Sp100 |
| 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 | NUM |
| 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 | 3073 |
| Device | Autoantibodies, Nuclear Body Protein, Sp100 |
| Product Code | NUM |
| 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 20:23:26