Product code GNE
- Device name
- Antigen, Latex Agglutination, T. Cruzi
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3870
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset