Biokit, S.A. FDA Approvals

0 new drug approvals and 5 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
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls510(k)Feb 12, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Feb 12, 2025
ADVIA Centaur EBV-EBNA IgG510(k)Aug 7, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Aug 7, 2024
ADVIA Centaur EBV-VCA IgM510(k)Aug 7, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Aug 7, 2024
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls510(k)Sep 20, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Sep 20, 2023
Quantia IgE510(k)Feb 21, 2023Immunology	Immunology	510(k)Substantially Equivalent (Special)	Feb 21, 2023