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Centers for Disease Control and Prevention

FDA 510(k) & PMA Approved 기기 — 13 products

총 기기 수13
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최신 FDA 결정
유형번호기기명코드날짜작업
510(k) K260812 Francisella tularensis Real-time PCR AssaySGA2026-03-30 보기
510(k) K252072 Francisella tularensis Real-time PCR assaySGA2025-09-30 보기
510(k) K243274 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 Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)OZE2025-07-11 보기
510(k) 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)OZE2025-03-14 보기
510(k) K241110 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)OZE2024-05-21 보기
510(k) K222558 Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK2022-08-30 보기
510(k) K221834 Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK2022-06-24 보기
510(k) K221658 Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK2022-06-10 보기
510(k) K200370 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping KitOZE2020-03-10 보기
510(k) K192871 B. anthracis Real-time PCR AssayNHT2019-11-07 보기
510(k) K190302 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping KitOZE2019-03-27 보기
510(k) K181205 Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK2018-09-20 보기
510(k) K172091 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping KitOZE2017-08-09 보기
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