NBO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- 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 |
|---|---|---|
| EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) (K091969) | Euroimmun Us, Inc. | 2010-09-02 |
| RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E (K000336) | Rhigene, Inc. | 2000-06-09 |
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Every clearance here is in the API, with alerts when new ones post.