MIZ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3320
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 (K101407) | Immuno-Mycologics, Inc. | 2011-07-19 |
| PERMIER HISTOPLASMA (K915700) | Meridian Diagnostics, Inc. | 1992-07-30 |
Track MIZ automatically
Every clearance here is in the API, with alerts when new ones post.