Product code PIT
- Device name
- Leishmania Spp. Antigen Detection Assay
- 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
- Definition
- An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.
- Source
- FDA openFDA device classification dataset