Quick Vue Influenza
FDA 510(k) K131599 · Quidel Corporation
510(k) numberK131599
Submission
- Device name
- Quick Vue Influenza
- Applicant
- Quidel Corporation
San Diego, CA, US - Received
- June 3, 2013
- Decision date
- July 5, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GNX – Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3330
- Specialty
- Microbiology
Other 510(k)s with product code GNX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133411 | Alere Binaxnow Influenza a & B CardGNX · Special | Alere Scarborough, Inc D/B/A Binax, Inc. | 12/05/2013SE |
| K132352 | SAS Flualert a & B, SAS Influenza a TestGNX · Special | Sa Scientific , Ltd. | 08/22/2013SE |
| K131804 | Remel Xpect Flu A&BGNX · Special | Remel, Inc. | 07/12/2013SE |
| K131606 | Sofia Influenza A+B FiaGNX · Special | Quidel Corp. | 07/05/2013SE |
| K131619 | Quickvue Influenza A+BGNX · Special | Quidel Corp. | 06/28/2013SE |
| K123182 | Osom Influenza A&B Test Model 190GNX · Special | SEKISUI Diagnostics, LLC | 11/05/2012SE |
| K971494 | Virazyme Influenza Id Test for Influenza Types a and B VirusesGNX · Traditional | Zymetx, Inc. | 09/10/1997SE |
| K924006 | Bartel Prima System Influenza a Enzyme ImmunoassayGNX · Traditional | Baxter Healthcare Corp | 12/29/1992SE |
| K901493 | Fitc Murine Monoclonal Anti-Influenza Type BGNX · Traditional | Whittaker Bioproducts, Inc. | 06/27/1990SE |
| K893579 | Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional | Whittaker Bioproducts, Inc. | 01/16/1990SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K231795 | QuickVue COVID-19 TestQYT · Traditional | 03/22/2024SE |
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| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetQVF · Special | 12/13/2023SE |
| K230349 | Lyra RSV+hMPV AssayOEM · Special | 03/10/2023SE |
| K230236 | Lyra Influenza A+B AssayOZE · Special | 03/03/2023SE |
| K211342 | Sofia 2 Campylobacter FIALQP · Traditional | 11/23/2021SE |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control SetLSR · Dual Track | 08/30/2018SE |
| K181029 | Solana Bordetella Complete AssayOZZ · Traditional | 07/15/2018SE |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackLSR · Traditional | 02/28/2018SE |
| K180288 | QuickVue Influenza A+BPSZ · Special | 02/13/2018SE |
Questions and answers
When was Quick Vue Influenza cleared by the FDA?
Quick Vue Influenza (K131599) received a 510(k) decision of Substantially Equivalent on July 5, 2013, 32 days after the submission was received.
What is the product code of K131599?
The FDA product code is GNX – Antigens, Cf (Including Cf Control), Influenza Virus A, B, C, a Class I (low risk) device regulated under 21 CFR 866.3330.