Gold Standard Diagnostics FDA Approvals

0 new drug approvals and 4 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
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit510(k)Mar 22, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit510(k)Mar 22, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit510(k)Mar 22, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit510(k)Mar 22, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Mar 22, 2021