FDA product code NHY: Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus
NHY is the FDA product code for assay, direct, nucleic acid amplification, respiratory syncytial virus. It is a Class I device, regulated under 21 CFR 866.3480 and reviewed by the Microbiology panel. Devices under NHY reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3480 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NHY devices
openFDA lists no recalls for product code NHY.
Frequently asked questions
What is FDA product code NHY?
NHY is the FDA product code for assay, direct, nucleic acid amplification, respiratory syncytial virus. It is a Class I device, regulated under 21 CFR 866.3480 and reviewed by the Microbiology panel.
What device class is NHY?
Class I, regulation 21 CFR 866.3480. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NHY
- Run a recall and safety report across every NHY manufacturer
- Watch product code NHY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.