GSN
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antiserum, Positive And Negative Febrile Antigen Control Serum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3085
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM (K952145) | Sa Scientific, Inc. | 1995-07-18 |
| IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL (K885113) | Investigacion Farmaceutica S.A. DE C.V. | 1989-08-15 |
| NEGATIVE CONTROL SERUM FOR CF RO ID (K791385) | Immuno-Mycologics, Inc. | 1979-08-16 |
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Every clearance here is in the API, with alerts when new ones post.