FDA product code NIA: Assay, Direct, Nucleic Acid Amplification, Influenza Virus
NIA is the FDA product code for assay, direct, nucleic acid amplification, influenza virus. It is a Class I device, regulated under 21 CFR 866.3330 and reviewed by the Microbiology panel. Devices under NIA 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 Influenza 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, Influenza Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3330 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NIA devices
openFDA lists no recalls for product code NIA.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0008 — Administration of influenza virus vaccine
Frequently asked questions
What is FDA product code NIA?
NIA is the FDA product code for assay, direct, nucleic acid amplification, influenza virus. It is a Class I device, regulated under 21 CFR 866.3330 and reviewed by the Microbiology panel.
What device class is NIA?
Class I, regulation 21 CFR 866.3330. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NIA
- Run a recall and safety report across every NIA manufacturer
- Watch product code NIA 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.