Product code OEG
- Device name
- Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5660
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- The device is intended as an aid in the diagnosis of bullous pemphigoid.
- Source
- FDA openFDA device classification dataset