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NIAClass I

Assay, Direct, Nucleic Acid Amplification, Influenza Virus

21 CFR 866.3330 / Microbiology
FDA source (opens on fda.gov)

NIA is the FDA product code for Assay, Direct, Nucleic Acid Amplification, Influenza Virus, a class I device type, regulated under 21 CFR 866.3330. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NIA
Device name
Assay, Direct, Nucleic Acid Amplification, Influenza Virus
FDA 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.
Regulation
21 CFR 866.3330
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code