Product code OUZ
- Device name
- Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
- 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
- N
- Summary malfunction reporting
- Eligible
- Definition
- Detection of Leishmania species in skin lesions.
- Source
- FDA openFDA device classification dataset