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DiaSorin Molecular LLC: FDA-registered device maker in Cypress, CA, United States, 29 510(k) clearances

Name: DiaSorin Molecular LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

DiaSorin Molecular LLC is registered with the FDA (registration 2023365) in Cypress, CA, United States. It lists 41 device types. The FDA files 29 510(k) clearances under its listings, the newest dated June 15, 2026. 14 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2023365
Address: 11331 Valley View St, Cypress, CA, United States, 90630
Owner or operator: DiaSorin Molecular LLC (9089763)
Roles: Manufacturer, Manufacturer for export, Specification developer
First device listed: June 19, 1998
Registered through: 2026
Brand names listed: 3M Integrated Cycler, Anaplasma phagocytophilum IFA IgG - IF1450G, Anaplasma phagocytophilum IFA IgM - IF1450M, Arbovirus IFA IgM, Bartonella IFA IgG - IF1300G, Bartonella IFA IgM - IF1300M, Chlamydia MIF IgA & Chlamydia MIF IgG & Chlamydia MIF IgM, EL0100G - Parvovirus B19 DxSelect IgG Kit and more

Devices it lists

Device	Product code	Class	Role	Source
Anti-Jcv Antibody Detection Assay	OYP	2	Manufacturer	accessdata.fda.gov
Antigen, B. Pertussis	GOX	1	Manufacturer for export	accessdata.fda.gov
Antigen, Cf (Including Cf Control), Epstein-Barr Virus	GNQ	1	Manufacturer for export	accessdata.fda.gov
Antisera, Cf, Equine Encephalitis Virus, Eee, Wee	GQC	1	Manufacturer	accessdata.fda.gov
Antisera, Fluorescent, Chlamydia Spp.	LKI	1	Manufacturer for export	accessdata.fda.gov
Antiserum, Fluorescent, Q Fever	GPJ	1	Manufacturer	accessdata.fda.gov
Antiserum, Typhus Fever	GPN	1	Manufacturer	accessdata.fda.gov
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg	MYL	3	Manufacturer for export	accessdata.fda.gov
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm	MYM	3	Manufacturer for export	accessdata.fda.gov
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	PMN	2	Manufacturer	accessdata.fda.gov
Bordetella Pertussis Dna Assay System	OZZ	2	Manufacturer	accessdata.fda.gov
C. Difficile Nucleic Acid Amplification Test Assay	OMN	1	Manufacturer	accessdata.fda.gov
C. Difficile Toxin Gene Amplification Assay	OZN	2	Manufacturer	accessdata.fda.gov
C. Trachomatis (Chlamydia Group)	MGM	1	Manufacturer for export	accessdata.fda.gov
Cytomegalovirus (Cmv) Dna Quantitative Assay	PAB	2	Manufacturer for export	accessdata.fda.gov
Dengue Serological Reagents	OSU	2	Manufacturer for export	accessdata.fda.gov
Device To Detect Microbial Colonization Directly From Clinical Specimens.	SBT	2	Manufacturer	accessdata.fda.gov
Device, General Purpose, Microbiology, Diagnostic	LIB	1	Manufacturer	accessdata.fda.gov
Elisa, Antibody, West Nile Virus	NOP	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	LGC	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	MXJ	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	MYF	2	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	PGX	2	Manufacturer	accessdata.fda.gov
Herpes Simplex Virus Nucleic Acid Amplification Assay	OQO	2	Manufacturer	accessdata.fda.gov
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	PGI	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel	PGH	2	Manufacturer	accessdata.fda.gov
Internal Polymerase Chain Reaction Control, Not Assay Specific	OLD	1	Manufacturer	accessdata.fda.gov
Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System	PLO	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls Unassayed	OHQ	1	Manufacturer	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Manufacturer	accessdata.fda.gov
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	NJR	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna	QLX	2	Manufacturer for export	accessdata.fda.gov
Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection	QDZ	2	Manufacturer	accessdata.fda.gov
Reagent, Rickettsia Serological	LSQ	1	Manufacturer	accessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic Acid	QJR	N	Manufacturer	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Manufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Manufacturer, Specification developer	accessdata.fda.gov
Research Use Only/Microbiology	OTT	N	Manufacturer for export	accessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay System	OCC	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 15, 2026	K260333	LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit	PGX	Substantially Equivalent	Diasorin Molecular, LLC	accessdata.fda.gov
December 23, 2025	K251978	LIAISON NES FLU A/B, RSV & COVID-19	QOF	Substantially Equivalent	Diasorin Molecular, LLC	accessdata.fda.gov
October 30, 2025	K252387	Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)	QOF	Substantially Equivalent	Diasorin Molecular, LLC	accessdata.fda.gov
July 15, 2024	DEN230092	Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)	SBT	Unknown	Diasorin Molecular, LLC	accessdata.fda.gov
March 17, 2023	K220963	Simplexa COVID-19 & Flu A/B Direct	QOF	Substantially Equivalent	Diasorin Molecular, LLC	accessdata.fda.gov
November 5, 2022	K202755	Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack	QDZ	Substantially Equivalent	Diasorin Molecular, LLC	accessdata.fda.gov
August 22, 2020	K201505	Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack	OCC	Substantially Equivalent	Diasorin Molecular, LLC	accessdata.fda.gov
November 26, 2019	K192376	Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack	PGI	Substantially Equivalent	Diasorin Molecular, LLC	accessdata.fda.gov
May 13, 2019	K190219	Simplexa VZV Direct, Simplexa VZV Positive Control Pack	PLO	Substantially Equivalent	Diasorin Molecular, LLC	accessdata.fda.gov
November 7, 2018	K182467	Simplexa GBS Direct, Simplexa GBS Positive Control Pack	NJR	Substantially Equivalent	Diasorin Molecular, LLC	accessdata.fda.gov
August 13, 2018	K173498	Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack	OZZ	Substantially Equivalent	Diasorin Molecular, LLC	accessdata.fda.gov
February 14, 2017	K163085	Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack	OZN	Substantially Equivalent	Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC	accessdata.fda.gov
September 21, 2015	K152408	Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack	OCC	Substantially Equivalent	Focus Diagnostics, Inc.	accessdata.fda.gov
August 28, 2015	K150962	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack	OQO	Substantially Equivalent	Focus Diagnostics	accessdata.fda.gov
March 18, 2015	K143651	Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack	PGX	Substantially Equivalent	Focus Diagnostics, Inc.	accessdata.fda.gov
March 21, 2014	DEN130049	SIMPLEXA HSV 1&2 DIRECT	PGH	Unknown	Focus Diagnostics	accessdata.fda.gov
August 16, 2012	K120986	STRATIFY JCV DXSELECT	OYP	Substantially Equivalent	Focus Diagnostics, Inc.	accessdata.fda.gov
April 4, 2012	K113433	SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT	OMN	Substantially Equivalent	Focus Diagnostics, Inc.	accessdata.fda.gov
October 29, 2010	K102314	3M INTEGRATED CYCLER (110V) & (220V)	OOI	Substantially Equivalent	Focus Diagnostics, Inc.	accessdata.fda.gov
June 30, 2004	K040854	WEST NILE VIRUS IGM CAPTURE ELISA	NOP	Substantially Equivalent	Focus Technologies, Inc.	accessdata.fda.gov
October 22, 2003	K031953	WEST NILE VIRUS ELISA IGG, MODEL EL0300G	NOP	Substantially Equivalent	Focus Technologies, Inc.	accessdata.fda.gov
April 14, 2000	K000238	HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G	LGC	Substantially Equivalent	Mrl Diagnostics	accessdata.fda.gov
February 9, 2000	K993754	HSV-1 ELISA IGG, MODEL EL0910G	MXJ	Substantially Equivalent	Mrl Diagnostics	accessdata.fda.gov
February 1, 2000	K993724	HSV-2 ELISA IGG, MODEL EL0920G	MYF	Substantially Equivalent	Mrl Diagnostics	accessdata.fda.gov
December 3, 1992	K913618	ARBOVIRUS IGM IFA TEST	GQC	Substantially Equivalent	Hillcrest Biologicals	accessdata.fda.gov
December 3, 1992	K913617	ARBOVIRUS IGG IFA TEST	GQC	Substantially Equivalent	Hillcrest Biologicals	accessdata.fda.gov
October 21, 1992	K922374	Q FEVER IGM IFA TEST	GPJ	Substantially Equivalent	Hillcrest Biologicals	accessdata.fda.gov
October 21, 1992	K913906	Q FEVER IGG IFA TEST	GPJ	Substantially Equivalent	Hillcrest Biologicals	accessdata.fda.gov
March 12, 1987	K864110	RICKETTSIAL IGG AND IGM IFA KIT	GPN	Substantially Equivalent	Hillcrest Biologicals	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 14, 2023	92559	Class II	Ongoing	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 individually pouch-sealed and	There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.	accessdata.fda.gov
January 30, 2023	91504	Class II	Ongoing	Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2	Direct amplification Discs, used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.	accessdata.fda.gov
November 19, 2021	89098	Class II	Ongoing	Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455	A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.	accessdata.fda.gov
September 23, 2021	88825	Class II	Ongoing	SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051	Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.	accessdata.fda.gov
May 12, 2020	85744	Class II	Terminated	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 of HSV-1 and HSV-2 pr	Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.	accessdata.fda.gov
February 15, 2017	76619	Class II	Terminated	Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.	After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.	accessdata.fda.gov
February 10, 2016	73283	Class I	Terminated	Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455	Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.	accessdata.fda.gov
October 2, 2015	72395	Class II	Terminated	Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.	Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.	accessdata.fda.gov
March 15, 2015	70856	Class II	Terminated	STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.	Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential for false positive JCV results.	accessdata.fda.gov
May 15, 2014	68347	Class II	Terminated	Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument f	Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Am	accessdata.fda.gov
February 4, 2014	67436	Class II	Terminated	Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number M	Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals.	accessdata.fda.gov
January 10, 2014	67213	Class II	Terminated	Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differen	Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate.	accessdata.fda.gov
October 3, 2012	63387	Class III	Terminated	West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The F	The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.	accessdata.fda.gov
July 6, 2007	47459	Not yet classified	Terminated	HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera.	A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.	accessdata.fda.gov

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Updated June 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.