K243931

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)

510(k) number: K243931
Device name: 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 GA · US
Product code: OZE — Influenza A And Influenza B Multiplex Nucleic Acid A
Decision date: 2025-03-14
Date received: 2024-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Microbiology

PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K243931.pdf

Official FDA record: K243931

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.