GRY
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antigens, All, Leptospira Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3350
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA (K002024) | Panbio, Inc. | 2000-11-22 |
| LEPTOSPIROSIS IHA (K880417) | Hillcrest Biologicals | 1988-04-12 |
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Every clearance here is in the API, with alerts when new ones post.