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
FDA 510(k) K190302 · Centers for Disease Control and Prevention
Submission
- Device name
- 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
- Applicant
- Centers for Disease Control and Prevention
Atlanta, GA, US - Received
- February 12, 2019
- Decision date
- March 27, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OZE – Influenza A And Influenza B Multiplex Nucleic Acid Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
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…
Other 510(k)s with product code OZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional | Centers for Disease Control and Prevention | 07/11/2025SE |
| K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional | Centers for Disease Control and Prevention | 03/14/2025SE |
| K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit…OZE · Special | Centers for Disease Control and Prevention | 05/21/2024SE |
| K230236 | Lyra Influenza A+B AssayOZE · Special | Quidel Corporation | 03/03/2023SE |
| K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2OZE · Special | Abbott Diagnostics Scarborough, Inc. | 06/24/2022SE |
| K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…OZE · Special | Centers for Disease Control and Prevention | 03/10/2020SE |
| K182513 | FluChip-8G Influenza A+B AssayOZE · Traditional | Indevr, Inc. | 04/22/2019SE |
| K190204 | ID NOW Influenza A & B 2OZE · Special | Alere Scarborough, Inc. | 03/18/2019SE |
| K181736 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage…OZE · Special | Centers For Disease Control and Prevention (CDC) | 07/30/2018SE |
| K171641 | Accula Flu A/Flu B TestOZE · Dual Track | Mesa Biotech, Inc. | 02/06/2018SE |
More from Mesa Biotech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260812 | Francisella tularensis Real-time PCR AssaySGA · Special | 03/30/2026SE |
| K252072 | Francisella tularensis Real-time PCR assaySGA · Traditional | 09/30/2025SE |
| K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional | 07/11/2025SE |
| K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional | 03/14/2025SE |
| K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit…OZE · Special | 05/21/2024SE |
| K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK · Special | 08/30/2022SE |
| K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK · Special | 06/24/2022SE |
| K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK · Traditional | 06/10/2022SE |
| K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…OZE · Special | 03/10/2020SE |
| K192871 | B. anthracis Real-time PCR AssayNHT · Special | 11/07/2019SE |
Questions and answers
When was 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 cleared by the FDA?
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) received a 510(k) decision of Substantially Equivalent on March 27, 2019, 43 days after the submission was received.
What is the product code of K190302?
The FDA product code is OZE – Influenza A And Influenza B Multiplex Nucleic Acid Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3980.