Is this your brand? Sign in to claim ownership.

DiaSorin Molecular LLC

Last updated September 17, 2026

About

Diasorin is the global leader in Molecular Diagnostics and Immunodiagnostics market. Discover all Diasorin’s diagnostic solutions.

From the manufacturer's own website. Source

Information

Country: US
Address: 11331 Valley View St, CYPRESS, CA, 90630
Website: molecular.diasorin.com
LinkedIn: it.linkedin.com/company/diasorin
Facebook: facebook.com/diasorin
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2023365
DUNS Number: —

Catalogue (108)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Simplexa COVID-19 Direct	MOL4150	FDA UDI	Class II	Active
Integrated Cyler (110V)	MOL1001	FDA UDI	Class II	Active
Simplexa™ C. difficile Positive Control Pack	MOL2960	FDA UDI	Class II	Active
Prothrombin (FII) HyBeacon Gen II Primer Pair	MOL9773	FDA UDI	Class I	Active
West Nile Virus IgM Capture DxSelect™ Positive Control	EL0315	FDA UDI	Class II	Active
HerpeSelect ELISA Sample Diluent	EL0928	FDA UDI	Class II	Active
DxSelect™ Sample Diluent	EL1608	FDA UDI	Class II	Active
Legionella IFA Polyvalent Conjugate	IF0010	FDA UDI	Class II	Unknown
HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive Control	IB0913	FDA UDI	Class II	Active
Simplexa™ GBS Positive Control Pack	MOL3560	FDA UDI	Class II	Active
Integrated Cycler (220V)	MOL1011	FDA UDI	Class II	Active
West Nile Virus IgM Capture DxSelect™ IgM Cutoff Calibrator (0.3 mL)	EL0303	FDA UDI	Class II	Active
Simplexa™ Flu A/B & RSV Direct	MOL2650	FDA UDI	Class II	Unknown
Direct Amplification Disc Kit	MOL1455	FDA UDI	Class II	Active
West Nile Virus IgG DxSelect™ - IgG Antigen Wells	EL0351	FDA UDI	Class II	Active
Simplexa COVID-19 & Flu A/B Direct	MOL4250	FDA UDI	Class II	Active
DxSelect™ - Stop Reagent	EL0105	FDA UDI	Class II	Active
West Nile Virus IgM Capture DxSelect™ Anti-Flavivirus Conjugate	EL0302	FDA UDI	Class II	Active
HSV Serum Panel	EL0950	FDA UDI	Class II	Active
HerpeSelect® 2 ELISA IgG	EL0920G-5	FDA UDI	Class II	Active
Borrelia miyamotoi Primer Pair	MOL9203	FDA UDI	Class I	Active
DxSelect™ - 10X Wash Buffer	EL0405	FDA UDI	Class II	Active
DxSelect™ - Substrate Reagent	EL0009	FDA UDI	Class II	Active
Simplexa™ Bordetella Positive Control Pack	MOL2760	FDA UDI	Class II	Unknown
HSV-1 ELISA IgG High Positive Control	EL0905	FDA UDI	Class II	Active
Simplexa™ Group A Strep Positive Control Pack	MOL2860	FDA UDI	Class II	Active
HerpeSelect® 1 ELISA IgG	EL0910G	FDA UDI	Class II	Active
Factor V HyBeacon II Primer Pair	MOL9771	FDA UDI	Class I	Active
West Nile Virus IgG DxSelect™	EL0300G-5	FDA UDI	Class II	Active
HerpeSelect® 2 ELISA IgG	EL0920G	FDA UDI	Class II	Active
Simplexa™ Flu A/B & RSV Direct Gen II	MOL2655	FDA UDI	Class II	Active
HerpeSelect® 1 ELISA IgG	EL0910G-5	FDA UDI	Class II	Active
West Nile Virus IgG DxSelect™ IgG Cutoff Calibrator	EL0306	FDA UDI	Class II	Active
Simplexa COVID-19 & Flu A/B Positive Control Pack	MOL4260	FDA UDI	Class II	Active
West Nile Virus IgM Capture DxSelect™	EL0300M	FDA UDI	Class II	Active
Simplexa™ Influenza A H1N1 (2009)	MOL2500	FDA UDI	Class II	Unknown
West Nile Virus IgG DxSelect™	EL0300G	FDA UDI	Class II	Active
Legionella IFA	IF0950	FDA UDI	Class II	Unknown
Universal Disc Cover Tape	MOL1500	FDA UDI	Class II	Active
HSV-1 IgG Antigen Wells	EL0901	FDA UDI	Class II	Active
HSV-1 and HSV-2 Immunoblot IgG Negative Control	IB0910	FDA UDI	Class II	Active
Stratify Jcv™ Dxselect™	EL1950	FDA UDI	Class II	Active
HSV-2 ELISA IgG Cutoff Calibrator	EL0907	FDA UDI	Class II	Active
HSV-2 ELISA IgG Low Positive Control	EL0909	FDA UDI	Class II	Active
West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control	EL0311	FDA UDI	Class II	Active
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack	K202755	FDA 510(k)	Class II	Active
Simplexa GBS Direct, Simplexa GBS Positive Control Pack	K182467	FDA 510(k)	Class I	Active
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack	K192376	FDA 510(k)	Class II	Active
Simplexa VZV Direct, Simplexa VZV Positive Control Pack	K190219	FDA 510(k)	Class II	Active
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack	K173798	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 14, 2023	Z-2153-2023	—	open, classified	There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
Jan 30, 2023	Z-1210-2023	—	open, classified	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.
Jan 30, 2023	Z-1209-2023	—	open, classified	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.
Nov 19, 2021	Z-0457-2022	—	open, classified	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.
Sep 23, 2021	Z-0162-2022	—	open, classified	Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
May 12, 2020	Z-2547-2020	—	terminated	Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
May 12, 2020	Z-2549-2020	—	terminated	Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
May 12, 2020	Z-2548-2020	—	terminated	Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.