# Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests
> **Product code: QTU** · Not classified · Unknown · —
## Classification
- **FDA Product Code:** QTU
- **Device class:** Not classified
- **Regulation:** —
- **Review panel:** MI
- **Medical specialty:** Unknown
- **Submission type:** 7
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QTU)
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