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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 1 of 3

Device	Model / Reference	Registries	Class	Status
West Nile Virus IgM Capture DxSelect™	EL0300M-5	FDA UDI	Class II	Active
Simplexa™ C. auris Sample Prep Kit	MOL5390	FDA UDI	Class II	Active
IgM Capture Wells	EL1521	FDA UDI	Class II	Active
Simplexa™ VZV Direct	MOL3650	FDA UDI	Class II	Active
Simplexa™ C.difficile Sample Prep Kit	MOL5290	FDA UDI	Class II	Active
Simplexa™ Flu A/B & RSV	MOL2600	FDA UDI	Class II	Active
HerpeSelect® 1 and 2 Immunoblot IgG	IB0900G	FDA UDI	Class II	Active
Measles Virus Primer Pair	MOL9207	FDA UDI	Class I	Active
HSV-1 ELISA IgG Conjugate	EL0916	FDA UDI	Class II	Active
HSV-2 ELISA IgG High Positive Control	EL0908	FDA UDI	Class II	Active
Direct Amplification Disc	MOL1451	FDA UDI	Class II	Active
Universal Disc	MOL1401	FDA UDI	Class II	Active
West Nile Virus IgG DxSelect™ - IgG Conjugate	EL0304	FDA UDI	Class II	Active
Simplexa™ C. difficile Direct	MOL2950	FDA UDI	Class II	Active
Simplexa™ VZV Positive Control Pack	MOL3660	FDA UDI	Class II	Active
Simplexa COVID-19 Positive Control GEN II Pack	MOL4165	FDA UDI	Class II	Active
HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen Strips	IB0901	FDA UDI	Class II	Active
HSV-1 ELISA IgG Low Positive Control	EL0906	FDA UDI	Class II	Active
Direct Amplification Disc	MOL1451	FDA UDI	Class II	Active
Monkeypox Primer Pair	MOL9202	FDA UDI	Class I	Active
HSV ELISA Negative Control	EL0904	FDA UDI	Class II	Active
Legionella IFA Non-Detectable Control	IF0913	FDA UDI	Class II	Unknown
DxSelect™ Amber Sample Diluent	EL1708	FDA UDI	Class II	Unknown
Legionella IFA Substrate Slides	IF0951	FDA UDI	Class II	Unknown
Human GAPDH Endogenous Primer Pair	MOL9178	FDA UDI	Class I	Active
Simplexa™ GBS Direct	MOL3550	FDA UDI	Class II	Active
Simplexa™ C. auris Positive Control Pack	MOL3960	FDA UDI	Class II	Active
Simplexa™ Bordetella Direct	MOL2750	FDA UDI	Class II	Unknown
HSV-1 ELISA IgG Cutoff Calibrator	EL0903	FDA UDI	Class II	Active
Simplexa™ HSV 1 & 2 Direct	MOL2150	FDA UDI	Class II	Active
Simplexa™ VZV Swab Direct	MOL3655	FDA UDI	Class II	Active
Integrated Cycler (220V) Pre-Owned	MOL1011-P	FDA UDI	Class II	Active
Simplexa Congenital CMV Direct	MOL2255	FDA UDI	Class II	Active
Simplexa™ C. auris Direct	MOL3950	FDA UDI	Class II	Active
Simplexa™ Group A Strep Direct	MOL2850	FDA UDI	Class II	Active
Histoplasma DxSelect™	EL1700	FDA UDI	Class II	Unknown
Simplexa COVID-19 Positive Control Pack	MOL4160	FDA UDI	Class II	Active
HSV-2 ELISA IgG Conjugate	EL0917	FDA UDI	Class II	Active
West Nile Virus IgM Capture DxSelect™ Antigen	EL0322	FDA UDI	Class II	Active
West Nile Virus DxSelect™ Negative Control	EL0312	FDA UDI	Class II	Active
Simplexa™ Spectral Calibration Panel	SC1100	FDA UDI	N/A	Active
HSV-2 IgG Antigen Wells	EL0902	FDA UDI	Class II	Active
Universal Disc	MOL1400	FDA UDI	Class II	Active
Legionella IFA Detectable Control	IF0914	FDA UDI	Class II	Unknown
Simplexa™ Flu A/B & RSV Positive Control Pack	MOL2660	FDA UDI	Class II	Active
Simplexa™ C. difficile Universal Direct	MOL2975	FDA UDI	Class I	Active
Stratify Jcv™ Dxselect™	EL1950-5	FDA UDI	Class II	Active
Simplexa Congenital CMV Positive Control Pack	MOL2265	FDA UDI	Class II	Active
Integrated Cyler (110V) Pre-Owned	MOL1001-P	FDA UDI	Class II	Active
Simplexa™ HSV 1 & 2 Positive Control Pack	MOL2160	FDA UDI	Class II	Active

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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.