Quidel Corporation
FDA 510(k) & PMA Approved Devices — 22 products
Total Devices22
Categories16
Latest FDA decision2024-03-22
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K231795 | QuickVue COVID-19 Test | QYT | 2024-03-22 | View |
| 510(k) | K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | PGI | 2023-12-20 | View |
| 510(k) | K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | QVF | 2023-12-13 | View |
| 510(k) | K230349 | Lyra RSV+hMPV Assay | OEM | 2023-03-10 | View |
| 510(k) | K230236 | Lyra Influenza A+B Assay | OZE | 2023-03-03 | View |
| 510(k) | K211342 | Sofia 2 Campylobacter FIA | LQP | 2021-11-23 | View |
| 510(k) | K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control Set | LSR | 2018-08-30 | View |
| 510(k) | K181029 | Solana Bordetella Complete Assay | OZZ | 2018-07-15 | View |
| 510(k) | K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack | LSR | 2018-02-28 | View |
| 510(k) | K180288 | QuickVue Influenza A+B | PSZ | 2018-02-13 | View |
| 510(k) | K171976 | Sofia Strep A+ FIA, Sofia 2 Analyzer | GTY | 2017-12-21 | View |
| 510(k) | K173250 | Solana GBS Assay | NJR | 2017-12-21 | View |
| 510(k) | K163713 | Sofia Lyme FIA, Sofia Lyme Control Set | LSR | 2017-10-20 | View |
| 510(k) | K171974 | Solana RSV+hMPV Assay | OCC | 2017-10-16 | View |
| 510(k) | K170491 | Solana C. difficile Assay | OZN | 2017-05-11 | View |
| 510(k) | K162438 | Sofia Influenza A+B FIA on Sofia 2 | PSZ | 2017-04-14 | View |
| 510(k) | K162911 | Sofia RSV FIA on Sofia 2 analyzer | GQG | 2017-02-22 | View |
| 510(k) | K162451 | Solana HSV 1+2/VZV Assay | PGI | 2016-11-28 | View |
| 510(k) | K162274 | Solana Strep Complete Assay | PGX | 2016-10-25 | View |
| 510(k) | K161814 | Solana Influenza A+B Assay | OCC | 2016-09-27 | View |
No matching devices.
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