Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) FDA Approvals

0 new drug approvals and 3 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
Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA510(k)Sep 4, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Sep 4, 2026
Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA510(k)Sep 4, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Sep 4, 2026
Sofia Lyme FIA; Sofia 2 Campylobacter FIA510(k)Jul 10, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jul 10, 2026