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Centers for Disease Control and Prevention

30 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Francisella tularensis Real-time PCR Assay (K260812)Centers for Disease Control and Prevention2026-03-30
Francisella tularensis Real-time PCR assay (K252072)Centers for Disease Control and Prevention2025-09-30
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) (K243274)Centers for Disease Control and Prevention2025-07-11
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) (K243931)Centers for Disease Control and Prevention2025-03-14
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) (K241110)Centers for Disease Control and Prevention2024-05-21
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K222558)Centers for Disease Control and Prevention2022-08-30
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221834)Centers for Disease Control and Prevention2022-06-24
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221658)Centers for Disease Control and Prevention2022-06-10
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 Kit (K200370)Centers for Disease Control and Prevention2020-03-10
B. anthracis Real-time PCR Assay (K192871)Centers for Disease Control and Prevention2019-11-07
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 Kit (K190302)Centers for Disease Control and Prevention2019-03-27
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET (DEN070001)Centers for Disease Control and Prevention2018-09-21
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K181205)Centers for Disease Control and Prevention2018-09-20
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 Kit (K172091)Centers for Disease Control and Prevention2017-08-09
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING (K141859)Centers for Disease Control and Prevention2014-08-01
INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K140857)Centers for Disease Control and Prevention2014-04-25
INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K140851)Centers for Disease Control and Prevention2014-04-25
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K132508)Centers for Disease Control and Prevention2013-09-23
QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS (DEN130005)Centers for Disease Control and Prevention2013-08-08
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K130551)Centers for Disease Control and Prevention2013-05-22
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K123905)Centers for Disease Control and Prevention2013-01-14
CDC DENV-1-4 REAL TIME RT-PCT ASSAY (DEN120012)Centers for Disease Control and Prevention2012-05-24
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K111507)Centers for Disease Control and Prevention2011-08-23
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL (K101564)Centers for Disease Control and Prevention2010-06-22
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL (K080570)Centers for Disease Control and Prevention2008-09-30
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET (DEN060008)Centers for Disease Control and Prevention2006-02-03
SYNTHETIC VDRL ANTIGEN (K993633)Centers for Disease Control and Prevention2000-02-23
SERA FOR ANTINUCLEAR ANTIBODIES (K820945)Centers for Disease Control and Prevention1982-10-26
LEGIONELLA INDIRECT FLUOR. ANTIBODY (K812007)Centers for Disease Control and Prevention1981-09-08
LEGIONELLA DIRECT FLUORESCENT ANTIBODY (K812006)Centers for Disease Control and Prevention1981-09-08

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Every clearance here is in the API, with alerts when new ones post.