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Diasorin Molecular, LLC

14 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit (K260333)Diasorin Molecular, LLC2026-06-15
LIAISON NES FLU A/B, RSV & COVID-19 (K251978)Diasorin Molecular, LLC2025-12-23
Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) (K252387)Diasorin Molecular, LLC2025-10-30
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) (DEN230092)Diasorin Molecular, LLC2024-07-15
Simplexa COVID-19 & Flu A/B Direct (K220963)Diasorin Molecular, LLC2023-03-17
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack (K202755)Diasorin Molecular, LLC2022-11-05
Simplexa COVID-19 Direct (K212147)Diasorin Molecular, LLC2022-09-13
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack (K201505)Diasorin Molecular, LLC2020-08-22
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack (K192376)Diasorin Molecular, LLC2019-11-26
Simplexa VZV Direct, Simplexa VZV Positive Control Pack (K190219)Diasorin Molecular, LLC2019-05-13
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (K183223)Diasorin Molecular, LLC2018-12-19
Simplexa GBS Direct, Simplexa GBS Positive Control Pack (K182467)Diasorin Molecular, LLC2018-11-07
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (K173498)Diasorin Molecular, LLC2018-08-13
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (K173798)Diasorin Molecular, LLC2018-03-14

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Every clearance here is in the API, with alerts when new ones post.