# Influenza A Virus Subtype Differentiation Nucleic Acid Assay
> **Product code: OEP** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3980
## Classification
- **FDA Product Code:** OEP
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3980
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture.  Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses.  Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 11
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OEP)
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