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Diasorin Molecular, LLC

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories9
Latest Approval2025-12-23
TypeNumberDevice NameCodeDate
510(k) K251978 LIAISON NES FLU A/B, RSV & COVID-19 QOF 2025-12-23 View
510(k) K252387 Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) QOF 2025-10-30 View
510(k) DEN230092 Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) SBT 2024-07-15 View
510(k) K220963 Simplexa COVID-19 & Flu A/B Direct QOF 2023-03-17 View
510(k) K202755 Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack QDZ 2022-11-05 View
510(k) K212147 Simplexa COVID-19 Direct QQX 2022-09-13 View
510(k) K201505 Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack OCC 2020-08-22 View
510(k) K192376 Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack PGI 2019-11-26 View
510(k) K190219 Simplexa VZV Direct, Simplexa VZV Positive Control Pack PLO 2019-05-13 View
510(k) K183223 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack OZZ 2018-12-19 View
510(k) K182467 Simplexa GBS Direct, Simplexa GBS Positive Control Pack NJR 2018-11-07 View
510(k) K173498 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack OZZ 2018-08-13 View
510(k) K173798 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack PGI 2018-03-14 View
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