Genabio Diagnostics, Inc. FDA Approvals

0 new drug approvals and 2 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
GenaCheck COVID-19 Rapid Self-Test510(k)Sep 5, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Sep 5, 2025
GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)510(k)Aug 28, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 28, 2024