OZE — Influenza A And Influenza B Multiplex Nucleic Acid Assay Class II
Classification Details
- Product Code
- OZE
- Device Class
- Class II
- Regulation Number
- 866.3980
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243274 | centers for disease control and prevention | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typin | July 11, 2025 |
| K243931 | centers for disease control and prevention | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typin | March 14, 2025 |
| K241110 | centers for disease control and prevention | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtypi | May 21, 2024 |
| K230236 | quidel corporation | Lyra Influenza A+B Assay | March 3, 2023 |
| K220801 | abbott diagnostics scarborough | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | June 24, 2022 |
| K200370 | centers for disease control and prevention | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin | March 10, 2020 |
| K182513 | indevr | FluChip-8G Influenza A+B Assay | April 22, 2019 |
| K190302 | centers for disease control and prevention | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin | March 27, 2019 |
| K190204 | alere scarborough | ID NOW Influenza A & B 2 | March 18, 2019 |
| K181736 | centers for disease control and prevention (cdc) | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage | July 30, 2018 |
| K171641 | mesa biotech | Accula Flu A/Flu B Test | February 6, 2018 |
| K172091 | centers for disease control and prevention | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin | August 9, 2017 |
| K161556 | centers for disease control and prevention (cdc) | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtypi | June 30, 2016 |
| K153148 | centers for disease control and prevention (cdc) | CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Sub | December 1, 2015 |
| K141859 | centers for disease control and prevention | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBT | August 1, 2014 |
| K140857 | centers for disease control and prevention | INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR D | April 25, 2014 |
| K133869 | center for disease control and prevention (cdc) | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPIN | January 17, 2014 |
| K132508 | centers for disease control and prevention | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | September 23, 2013 |
| K131728 | quidel | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | August 29, 2013 |
| K113777 | quidel | QUIDEL MOLECULAR INFLUENZA A+B | March 15, 2012 |