MDU
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antigen, Elisa, Cryptococcus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3165
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ALPHA CRYPTOCOCCAL ANTIGEN EIA (K120946) | Immuno-Mycologics, Inc. | 2012-12-17 |
| PREMIER-CRYPTOCOCCAL ANTIGEN (K904393) | Meridian Diagnostics, Inc. | 1991-01-25 |
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Every clearance here is in the API, with alerts when new ones post.