Product code QKP
- Device name
- Coronavirus Antigen Detection Test System.
- 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
- The qualitative detection of coronavirus viral antigens directly from clinical specimens.
- Source
- FDA openFDA device classification dataset