# Diasorin Molecular, LLC

- Location (FDA's records): Cypress, CA
- FDA decisions: 14 (2018–2026): 13 510(k) clearances and 1 De Novo grant
- Product codes: QOF (3), OZZ (2), PGI (2), PLO (1), QDZ (1), QQX (1), NJR (1), OCC (1), SBT (1), PGX (1)
- 510(k) review time since 2016: median 179 days, against 178 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 11 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biofire Diagnostics, LLC: 3 (https://510kreport.com/company/biofire-diagnostics)
- Luminex Corporation: 1 (https://510kreport.com/company/luminex)
- Hologic, Inc.: 1 (https://510kreport.com/company/hologic)
- Meridian Bioscience, Inc.: 1 (https://510kreport.com/company/meridian-bioscience)
- Biofire Defense, LLC: 1 (https://510kreport.com/company/biofire-defense)
- Genepoc, Inc.: 1 (https://510kreport.com/company/genepoc)
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)
- Focus Diagnostics, Inc.: 1 (https://510kreport.com/company/focus-diagnostics)

## Firms that cite its devices most
- Visby Medical, Inc.: 1 (https://510kreport.com/company/visby-medical)
- Baebies, Inc.: 1 (https://510kreport.com/company/baebies)

## Its most-cited devices
- K220963: Simplexa COVID-19 & Flu A/B Direct (2023), cited by 2
- K173498: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (2018), cited by 1

## Recent decisions
- K260333: LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit (Jun 15, 2026)
- K251978: Liaison Nes Flu a/B, RSV & Covid-19 (Dec 23, 2025)
- K252387: Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) (Oct 30, 2025)
- DEN230092: Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) (Jul 15, 2024)
- K220963: Simplexa COVID-19 & Flu A/B Direct (Mar 17, 2023)
- K202755: Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack (Nov 5, 2022)
- K212147: Simplexa COVID-19 Direct (Sep 13, 2022)
- K201505: Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack (Aug 22, 2020)

Source page: https://510kreport.com/company/diasorin-molecular