Diasorin Molecular, LLC FDA Approvals

0 new drug approvals and 7 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
LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit510(k)Jun 15, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Jun 15, 2026
LIAISON NES FLU A/B, RSV & COVID-19510(k)Dec 23, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Dec 23, 2025
Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)510(k)Oct 30, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Oct 30, 2025
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)510(k)Jul 15, 2024Microbiology	Microbiology	510(k)Unknown (Direct)	Jul 15, 2024
Simplexa COVID-19 & Flu A/B Direct510(k)Mar 17, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Mar 17, 2023
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack510(k)Nov 5, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Nov 5, 2022
Simplexa COVID-19 Direct510(k)Sep 13, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Sep 13, 2022