FDA product code · Microbiology

Assay, Direct, Nucleic Acid Amplification, Influenza Virus

Name: FDA decisions, review times, recalls and adverse event reports for product code NIA
Creator: 510(k) Report

NIAClass I21 CFR 866.3330510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, microbiology panel

Twenty years of NIA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — NIA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NIA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 866.3330.

GNW Antisera, Cf, Influenza Virus A, B, C GNR Antisera, Neutralization, Influenza Virus A…GNT Antigens, Ha (Including Ha Control), Influenza…GNX Antigens, Cf (Including Cf Control), Influenza…GNS Antisera, Hai, Influenza Virus A, B, C