DEI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5130
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN (K840867) | Intl. Diagnostic Technology | 1984-05-11 |
| ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY (K772250) | Kallestad Laboratories, Inc. | 1977-12-22 |
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Every clearance here is in the API, with alerts when new ones post.