Devices Detecting Influenza A, B, And C Virus Antigens

PSZ · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3328

Classification

FDA Product Code: PSZ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3328
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.

Market data

Cleared 510(k) submissions: 72
Registered establishments: 35

Source

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