OEG
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA definition
- The device is intended as an aid in the diagnosis of bullous pemphigoid.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EUROIMMUN Anti-BP230-CF ELISA (IgG) (K193115) | Euroimmun Us, Inc. | 2020-09-17 |
| EUROIMMUN ANTI BP 180-4X ELISA (IGG) (K083615) | Euroimmun Us, Inc. | 2009-03-16 |
| MESACUP MODELS BP180 AND BP230 ELISA KITS (K071961) | Mbl International Corporation | 2008-08-25 |
Track OEG automatically
Every clearance here is in the API, with alerts when new ones post.