Diasorin Molecular, LLC - FDA 510(k) Cleared Devices

Cleared Dec 23, 2025

LIAISON NES FLU A/B, RSV & COVID-19

K251978 · QOF

Microbiology · 179d

Cleared Oct 30, 2025

Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450)

K252387 · QOF

Microbiology · 91d

Not Cleared Jul 15, 2024

Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa...

DEN230092 · SBT

Microbiology · 200d

Cleared Mar 17, 2023

Simplexa COVID-19 & Flu A/B Direct

K220963 · QOF

Microbiology · 350d

Cleared Nov 05, 2022

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

K202755 · QDZ

Microbiology · 775d

Cleared Sep 13, 2022

Simplexa COVID-19 Direct

K212147 · QQX

Microbiology · 431d

Cleared Aug 22, 2020

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control...

K201505 · OCC

Microbiology · 78d

Cleared Nov 26, 2019

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

K192376 · PGI

Microbiology · 88d

Cleared May 13, 2019

Simplexa VZV Direct, Simplexa VZV Positive Control Pack

K190219 · PLO

Microbiology · 98d

Cleared Dec 19, 2018

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

K183223 · OZZ

Microbiology · 29d

Cleared Nov 07, 2018

Simplexa GBS Direct, Simplexa GBS Positive Control Pack

K182467 · NJR

Microbiology · 58d

Cleared Aug 13, 2018

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

K173498 · OZZ

Microbiology · 273d

Cleared Mar 14, 2018

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

K173798 · PGI

Microbiology · 90d