Diasorin Molecular, LLC - FDA 510(k) Cleared Devices
Recent clearances: LIAISON NES FLU A/B, RSV & COVID-19, Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450), Simplexa COVID-19 & Flu A/B Direct
14
Total
13
Cleared
1
Denied
FDA 510(k) Regulatory Record - Diasorin Molecular, LLC Microbiology ✕
14 devices
Cleared
Jun 15, 2026
LIAISON NES Group A Strep
Microbiology
133d
Cleared
Dec 23, 2025
LIAISON NES FLU A/B, RSV & COVID-19
Microbiology
179d
Cleared
Oct 30, 2025
Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450)
Microbiology
91d
Not Cleared
Jul 15, 2024
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa...
Microbiology
200d
Cleared
Mar 17, 2023
Simplexa COVID-19 & Flu A/B Direct
Microbiology
350d
Cleared
Nov 05, 2022
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
Microbiology
775d
Cleared
Sep 13, 2022
Simplexa COVID-19 Direct
Microbiology
431d
Cleared
Aug 22, 2020
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control...
Microbiology
78d
Cleared
Nov 26, 2019
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
Microbiology
88d
Cleared
May 13, 2019
Simplexa VZV Direct, Simplexa VZV Positive Control Pack
Microbiology
98d
Cleared
Dec 19, 2018
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
Microbiology
29d
Cleared
Nov 07, 2018
Simplexa GBS Direct, Simplexa GBS Positive Control Pack
Microbiology
58d