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OZE

20 FDA 510(k) clearances · Product code

42 daysmedian time to decision
249 days90th percentile
20clearances measured

FDA profile

Official device name
Influenza A And Influenza B Multiplex Nucleic Acid Assay
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3980
Medical specialty
Microbiology
FDA definition
An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.
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RecordFirmDate
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
Lyra Influenza A+B Assay (K230236)Quidel Corporation2023-03-03
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (K220801)Abbott Diagnostics Scarborough, Inc.2022-06-24
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
FluChip-8G Influenza A+B Assay (K182513)Indevr, Inc.2019-04-22
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
ID NOW Influenza A & B 2 (K190204)Alere Scarborough, Inc.2019-03-18
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, (K181736)Centers For Disease Control and Prevention (CDC)2018-07-30
Accula Flu A/Flu B Test (K171641)Mesa Biotech, Inc.2018-02-06
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 Subtyping Kit (K161556)Centers For Disease Control and Prevention (CDC)2016-06-30
CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping (K153148)Centers For Disease Control and Prevention (CDC)2015-12-01
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
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT (K133869)Center For Disease Control and Prevention (Cdc)2014-01-17
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K132508)Centers for Disease Control and Prevention2013-09-23
QUIDEL MOLECULAR INFLUENZA A + B ASSAY (K131728)Quidel Corp.2013-08-29
QUIDEL MOLECULAR INFLUENZA A+B (K113777)Quidel Corp.2012-03-15

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