FDA product code OEG
Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Immunology·Class 2·21 CFR 866.5660
US regulatory classifications
- US Product Code (FDA)
- OEGView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.5660View CFR Regulation →
- Medical specialty
- Immunology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
Definition
The device is intended as an aid in the diagnosis of bullous pemphigoid.
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About this record
Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.