Assay, Direct, Nucleic Acid Amplification, Influenza Virus

NIA · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3330

Classification

FDA Product Code: NIA
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 866.3330
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown