OEG — Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 Class II
FDA product code OEG covers "Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230", a Class II medical device regulated under 21 CFR 866.5660. Submissions are reviewed by the Immunology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OEG
- Device Class
- Class II
- Regulation Number
- 866.5660
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
The device is intended as an aid in the diagnosis of bullous pemphigoid.