Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008576040

FEI Number

3008576040

Entity Name

DiaSorin Italia S.p.A UK Branch

City/State/Country

Dartford Kent, GB

Establishment Address

Central Road, Dartford Kent DA1 5LR, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DiaSorin Inc. (Owner Number: 9051149)

Owner / Operator Contact Address

1951 Northwestern Ave, Stillwater, MN 55082, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LIAISON® MUREX Control HIV Ab/Ag HT LIAISON® MUREX HIV Ab/Ag HT LIAISON MUREX HCV Ab LIAISON MUREX Control HCV Ab LIAISON® diluteX LIAISON Light Check LIAISON Wash/System Liquid LIAISON XL Clean Tool LIAISON Light Check 12 LIAISON Starter kit LIAISON Clean Kit LIAISON XL Starter kit LIAISON Analyzer LIAISON XL Analyzer LIAISON XL MUREX Control HIV Ab/Ag HT LIAISON XL MUREX HIV Ab/Ag HT LIAISON XS Analyzer LIAISON Disposable Tips (x0055) LIAISON EASY Starter kit (319300) LIAISON EASY Wash Buffer (319301) LIAISON Anti-HAV LIAISON Cuvettes on tray (X0053) LIAISON EASY System Liquid LIAISON EASY Cleaning Tool (310996)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	1999-01-06
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2025-12-02
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2019-11-01
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2010-06-24
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2020-12-08
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2020-03-13
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2020-03-13

Official Correspondent

Mari Meyer

US Agent Details

Mari Meyer Business: DiaSorin Inc Email: mari.meyer@diasorin.com Phone: (651) 4399710

Related Public Records

Same Entity

DiaSorin Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012449645	DiaSorin Canada Inc.	Mississauga Ontario, CA
3004434309	DiaSorin Deutschland GmbH	Dietzenbach Hesse, DE
9610240	DiaSorin Italia S.p.A.	SALUGGIA Vercelli, IT
2182595	DIASORIN INC.	Stillwater, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K222850	Abbott Laboratories	HAVAb IgG II	2023-08-10
K081716	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR HAVM ASSAY	2008-07-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2020	Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands	1	V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008576040. Last updated year: 2026. Please use registration number 3008576040 when referencing this establishment in official correspondence.