# Reagents, 2019-Novel Coronavirus Nucleic Acid
> **Product code: QJR** · Not classified · Unknown · —
## Classification
- **FDA Product Code:** QJR
- **Device class:** Not classified
- **Regulation:** —
- **Review panel:** MI
- **Medical specialty:** Unknown
- **Submission type:** 8
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 59
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QJR)
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*AI Analytics · CC0 1.0*