# Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus
> **Product code: NHY** · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3480
## Classification
- **FDA Product Code:** NHY
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 866.3480
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

These reagents are nucleic acid primers and probes for the amplification and identification of Respiratory Syncytial virus directly from clinical specimens.  The identification aids in the diagnosis of influenza and provides epidemiological information on this disease.  This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera.

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