Quidel Corporation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Quidel Corporation - FDA 510(k) Cleared Devices
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
Quidel Corporation has 35 FDA 510(k) cleared microbiology devices. Based in San Diego, US.
Latest FDA clearance: Mar 2024. Active since 2010.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Quidelortho Corporation as regulatory consultant. 2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Quidel Corporation
37 devices
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
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
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