Panels › Microbiology › Product code OZE · Class 2
Influenza A And Influenza B Multiplex Nucleic Acid Assay
Regulation 866.3980
1510(k)s in 12 months (21 all time)
1recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in OZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Centers for Disease Control and Prevention | 10 | 1 |
| Abbott Diagnostics Scarborough, Inc. | 1 | 3 |
| Centers For Disease Control and Prevention (CDC) | 3 | 0 |
| Quidel Corp. | 3 | 0 |
| Alere Scarborough, Inc. | 1 | 0 |
| Center For Disease Control and Prevention (Cdc) | 1 | 0 |
| Indevr, Inc. | 1 | 0 |
| Luminex Corporation | 0 | 1 |
| Mesa Biotech, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2026 | K263035 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Ki Centers for Disease Control and Prevention | OZE |
| Jul 11, 2025 | K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit Centers for Disease Control and Prevention | OZE |
| Mar 14, 2025 | K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit Centers for Disease Control and Prevention | OZE |
| May 21, 2024 | K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) Centers for Disease Control and Prevention | OZE |
| Mar 3, 2023 | K230236 | Lyra Influenza A+B Assay Quidel Corporation | OZE |
| Jun 24, 2022 | K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 Abbott Diagnostics Scarborough, Inc. | OZE |
| Mar 10, 2020 | K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-ti Centers for Disease Control and Prevention | OZE |
| Apr 22, 2019 | K182513 | FluChip-8G Influenza A+B Assay Indevr, Inc. | OZE |
| Mar 27, 2019 | K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-ti Centers for Disease Control and Prevention | OZE |
| Mar 18, 2019 | K190204 | ID NOW Influenza A & B 2 Alere Scarborough, Inc. | OZE |
| Jul 30, 2018 | K181736 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, Centers For Disease Control and Prevention (CDC) | OZE |
| Feb 6, 2018 | K171641 | Accula Flu A/Flu B Test Mesa Biotech, Inc. | OZE |
| Aug 9, 2017 | K172091 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-ti Centers for Disease Control and Prevention | OZE |
| Jun 30, 2016 | K161556 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit Centers For Disease Control and Prevention (CDC) | OZE |
| Dec 1, 2015 | K153148 | CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Centers For Disease Control and Prevention (CDC) | OZE |
| Aug 1, 2014 | K141859 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING Centers for Disease Control and Prevention | OZE |
| Apr 25, 2014 | K140857 | INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention | OZE |
| Jan 17, 2014 | K133869 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT Center For Disease Control and Prevention (Cdc) | OZE |
| Sep 23, 2013 | K132508 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention | OZE |
| Aug 29, 2013 | K131728 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY Quidel Corp. | OZE |
| Mar 15, 2012 | K113777 | QUIDEL MOLECULAR INFLUENZA A+B Quidel Corp. | OZE |
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