Product code DBE
- Device name
- Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5120
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset