Product code QTU
- Device name
- Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests
- Medical specialty
- Unknown
- Device class
- N
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Antigen-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus or monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens-EXPORT ONLY
- Source
- FDA openFDA device classification dataset