DGE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Igd, Rhodamine, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- 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 |
|---|---|---|
| OPUS FERRITIN TEST SYSTEM (K915838) | Pb Diagnostic Systems, Inc. | 1992-03-18 |
| STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (K871972) | American Dade | 1987-07-21 |
Track DGE automatically
Every clearance here is in the API, with alerts when new ones post.