2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

OQW · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3332

Classification

FDA Product Code: OQW
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3332
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens

Market data

Cleared 510(k) submissions: 10
Registered establishments: 3

Source

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