Product code QJR
- Device name
- Reagents, 2019-Novel Coronavirus Nucleic Acid
- 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
- Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens.
- Source
- FDA openFDA device classification dataset