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) 号: K243931
器械名称: 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)
申请人: Centers for Disease Control and Prevention GA · US
产品代码: OZE — Influenza A And Influenza B Multiplex Nucleic Acid A
批准日期: 2025-03-14
受理日期: 2024-12-20
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Microbiology

PDF下载 510(k) Summary本站存档 · 2.6 MB · FDA 公有领域文件

也可从 FDA 官方下载： K243931.pdf

FDA 官方记录： K243931

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。