Luminex Molecular 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
NxTAG® Respiratory Pathogen Panel510(k)Oct 2, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Oct 2, 2024
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)510(k)Mar 11, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Mar 11, 2024