FDA product code NHZ: Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus
NHZ is the FDA product code for assay, direct, nucleic acid amplification, parainfluenza virus. It is a Class I device, regulated under 21 CFR 866.3400 and reviewed by the Microbiology panel. Devices under NHZ 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 Parainfluenza 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, Parainfluenza Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3400 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NHZ devices
openFDA lists no recalls for product code NHZ.
Frequently asked questions
What is FDA product code NHZ?
NHZ is the FDA product code for assay, direct, nucleic acid amplification, parainfluenza virus. It is a Class I device, regulated under 21 CFR 866.3400 and reviewed by the Microbiology panel.
What device class is NHZ?
Class I, regulation 21 CFR 866.3400. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NHZ
- Run a recall and safety report across every NHZ manufacturer
- Watch product code NHZ 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.