Quidel Corporation FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
QuickVue COVID-19 Test510(k)Mar 22, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Mar 22, 2024
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument510(k)Dec 20, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Dec 20, 2023
Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set510(k)Dec 13, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Dec 13, 2023
Lyra RSV+hMPV Assay510(k)Mar 10, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Mar 10, 2023
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set510(k)Mar 8, 2023Microbiology	Microbiology	510(k)Unknown (Post-NSE)	Mar 8, 2023
Lyra Influenza A+B Assay510(k)Mar 3, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Mar 3, 2023
Sofia 2 Campylobacter FIA510(k)Nov 23, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Nov 23, 2021