OZE

Accula Flu A/Flu B Test

Advisory panel: Microbiology
Total cleared: 20

Recent clearances under product code OZE

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) Centers for Disease Control and Prevention · 2025-07-11
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) Centers for Disease Control and Prevention · 2025-03-14
K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) Centers for Disease Control and Prevention · 2024-05-21
K230236 — Lyra Influenza A+B Assay Quidel Corporation · 2023-03-03
K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 Abbott Diagnostics Scarborough, Inc. · 2022-06-24
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 Kit Centers for Disease Control and Prevention · 2020-03-10
K182513 — FluChip-8G Influenza A+B Assay Indevr, Inc. · 2019-04-22
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 Kit Centers for Disease Control and Prevention · 2019-03-27
K190204 — ID NOW Influenza A & B 2 Alere Scarborough, Inc. · 2019-03-18
K181736 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, Centers For Disease Control and Prevention (CDC) · 2018-07-30
K171641 — Accula Flu A/Flu B Test Mesa Biotech, Inc. · 2018-02-06
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 Kit Centers for Disease Control and Prevention · 2017-08-09
K161556 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit Centers For Disease Control and Prevention (CDC) · 2016-06-30
K153148 — CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Centers For Disease Control and Prevention (CDC) · 2015-12-01
K141859 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING Centers for Disease Control and Prevention · 2014-08-01
K140857 — INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention · 2014-04-25
K133869 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT Center For Disease Control and Prevention (Cdc) · 2014-01-17
K132508 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention · 2013-09-23
K131728 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY Quidel Corp. · 2013-08-29
K113777 — QUIDEL MOLECULAR INFLUENZA A+B Quidel Corp. · 2012-03-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.