Product code OZE
- Device name
- Influenza A And Influenza B Multiplex Nucleic Acid Assay
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3980
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 Sub... | 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 Lineag... | 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 Lineag... | 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 |
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| 00857573006164 | Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge | NANOSPHERE, INC. | 2016-09-23 |
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| 30014613311003 | Lyra | DIAGNOSTIC HYBRIDS, INC. | 2016-09-15 |
| 00840487100158 | ARIES® Flu A/B & RSV Assay | LUMINEX CORPORATION | 2016-09-09 |
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