Medical Device Manufacturer · US , San Diego , CA

Quidel Corporation - FDA 510(k) Cleared Devices

37 submissions · 35 cleared · Since 2010

Recent clearances: QuickVue COVID-19 Test, Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument, Sofia 2 SARS Antigen+ FIA

37

Total

35

Cleared

2

Denied

FDA 510(k) Regulatory Record - Quidel Corporation Microbiology ✕

36 devices

1-12 of 36

Cleared Mar 22, 2024

QuickVue COVID-19 Test

Microbiology · 276d

Cleared Dec 20, 2023

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument

Microbiology · 141d

Cleared Dec 13, 2023

Sofia 2 SARS Antigen+ FIA

Microbiology · 26d

Cleared Mar 10, 2023

Lyra RSV+hMPV Assay

Microbiology · 29d

Not Cleared Mar 08, 2023

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

DEN220039 · QVF

Microbiology · 265d

Cleared Mar 03, 2023

Lyra Influenza A+B Assay

Microbiology · 32d

Cleared Nov 23, 2021

Sofia 2 Campylobacter FIA

Microbiology · 204d

Cleared Aug 30, 2018

Sofia 2 Lyme FIA, Sofia Lyme Control Set

Microbiology · 290d

Cleared Jul 15, 2018

Solana Bordetella Complete Assay

Microbiology · 88d

Cleared Feb 28, 2018

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack

Microbiology · 89d

Cleared Feb 13, 2018

QuickVue Influenza A+B

Microbiology · 12d

Cleared Dec 21, 2017

Sofia Strep A+ FIA, Sofia 2 Analyzer

Microbiology · 174d