Company · US
Diasorin Molecular, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (2 in 12 months)
8recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PGI | Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | 3 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 3 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 |
| OOI | Real Time Nucleic Acid Amplification System | 2 |
| OZZ | Bordetella Pertussis Dna Assay System | 2 |
| PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | 2 |
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | 2 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 |
| OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 1 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 1 |
| QDZ | Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection | 1 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | 1 |
| SBT | Device To Detect Microbial Colonization Directly From Clinical Specimens. | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 2026 | K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit Diasorin Molecular, LLC | PGX |
| Dec 23, 2025 | K251978 | LIAISON NES FLU A/B, RSV & COVID-19 Diasorin Molecular, LLC | QOF |
| Oct 30, 2025 | K252387 | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) Diasorin Molecular, LLC | QOF |
| Jul 15, 2024 | DEN230092 | Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, Diasorin Molecular, LLC | SBT |
| Mar 17, 2023 | K220963 | Simplexa COVID-19 & Flu A/B Direct Diasorin Molecular, LLC | QOF |
| Nov 5, 2022 | K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack Diasorin Molecular, LLC | QDZ |
| Sep 13, 2022 | K212147 | Simplexa COVID-19 Direct Diasorin Molecular, LLC | QQX |
| Aug 22, 2020 | K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack Diasorin Molecular, LLC | OCC |
| Nov 26, 2019 | K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack Diasorin Molecular, LLC | PGI |
| May 13, 2019 | K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack Diasorin Molecular, LLC | PLO |
| Dec 19, 2018 | K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack Diasorin Molecular, LLC | OZZ |
| Nov 7, 2018 | K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack Diasorin Molecular, LLC | NJR |
| Aug 13, 2018 | K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack Diasorin Molecular, LLC | OZZ |
| Mar 14, 2018 | K173798 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack Diasorin Molecular, LLC | PGI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2023 | DiaSorin Molecular LLC Simplexa Direct Amplification Disc Kit, Rx Only, IVD
The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individu Open, Classified |
OOI | None listed |
| Mar 3, 2023 | DiaSorin Molecular LLC Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5. Open, Classified |
OCC | K201505 |
| Mar 3, 2023 | DiaSorin Molecular LLC Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2 Open, Classified |
QJR | None listed |
| Nov 19, 2021 | DiaSorin Molecular LLC Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 Open, Classified |
OOI | None listed |
| Sep 23, 2021 | DiaSorin Molecular LLC SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051 Open, Classified |
QJR | None listed |
| Jul 10, 2020 | DiaSorin Molecular LLC MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutan Terminated |
PGI | K192376 |
| Jul 10, 2020 | DiaSorin Molecular LLC MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patie Terminated |
PLO | K190219 |
| Jul 10, 2020 | DiaSorin Molecular LLC MOL2150 Simplexa HSV 1&2 Direct
-CSF
-Genital Swab
-Cutaneous / Mucocutaneous Swabs
Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation o Terminated |
OQO | K141458 K150962 |