LIR
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GC OIA (K023947) | Thermo Biostar, Inc. | 2003-04-17 |
| ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL (K882534) | Abbott Laboratories | 1988-07-12 |
| HYGEIA GC TEST (K881064) | Hygeia Sciences | 1988-06-02 |
Track LIR automatically
Every clearance here is in the API, with alerts when new ones post.