CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) +3 more— 510(k) K243931

Clearance details

Device name as filed

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

Applicant

Centers for Disease Control and Prevention

Product code

Code OZE

Device class

Class 2

Regulation

21 CFR 866.3980

Advisory panel

Microbiology

Date received

2024-12-20

Decision date

2025-03-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Atlanta, GA, US

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