Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610240

FEI Number

3002808212

Entity Name

DiaSorin Italia S.p.A.

City/State/Country

SALUGGIA Vercelli, IT

Establishment Address

VIA CRESCENTINO, snc, SALUGGIA Vercelli 13040, IT

Establishment Type(s)

Manufacture Medical Device

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

K040120

PMA Number

N/A

All Registered Proprietary Names

LIAISON Control Toxo IgG ll LIAISON Toxo IgG ll Parvovirus B19 IgM Enzyme Immunoassay LIAISON® XL HCG HUMAN GROWTH HORMONE LIAISON hGH LIAISON hGH control set LIAISON IGF-1 LIAISON® Control Toxo IgM II LIAISON® Toxo IgM II Parvovirus B19 IgG Enzyme Immunoassay LIAISON Anti-HAV LIAISON XL Analyzer Workcell Upgrade Kit ETI-AB-DELTAk2 ETI-AB-AUK-3 Negative Control ETI-AB-AUK-3 LIAISON XL MUREX Anti-HBe LIAISON XL MUREX Control Anti-HBe LIAISON VZV IgG HT LIAISON Control VZV IgG HT 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® MUREX Control HIV Ab/Ag HT LIAISON® MUREX HIV Ab/Ag HT LIAISON® Control QuantiFERON®-TB Gold Plus II LIAISON® QuantiFERON®-TB Gold Plus LIAISON® QuantiFERON® Software LIAISON® Control QuantiFERON®-TB Gold Plus LIAISON® QuantiFERON®-TB Gold Plus II LIAISON(R) Treponema Assay LIAISON(R)Treponema Control Set LIAISON® Control Rubella IgM LIAISON® Rubella IgM assay LIAISON Control Direct Renin LIAISON Direct Renin LIAISON FSH LIAISON Control Thyroid 1, LIAISON Control Thyroid 2, LIAISON Control Thyroid 3 LIAISON FT4 LIAISON Control Measles IgG LIAISON Measles IgG S100B ELISA TK-REA LIAISON NSE LIAISON TK LIAISON Rubella IgG LIAISON Rubella IgG Tri-Controls LIAISON BRAHMS PCT II GEN Verifiers LIAISON BRAHMS PCT II GEN LIAISON BRAHMS Control PCT II GEN ETI-EBK PLUS LIAISON Control Ferritin LIAISON Ferritin LIAISON Ferritin Calibration Verifiers LIAISON XL MUREX Control HBc IgM LIAISON XL MUREX HBc IgM LIAISON XL MUREX Control Anti-HBc LIAISON XL MUREX Anti-HBc LIAISON EBNA IgG Serum Control Set LIAISON VCA IgG Serum Control Set LIAISON(R) CMV IgM LIAISON(R) CMV IgG LIAISON(R) Control CMV IgG LIAISON(R) Control CMV IgM ETI-AB-EBK PLUS LIAISON® EBV IgM Serum Control Set LIAISON LH 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) LIAISON XL MUREX Control HBeAg LIAISON XL MUREX HBeAg LIAISON XL MUREX HBsAg Confirmatory Test LIAISON XL MUREX HBsAg Qual LIAISON XL MUREX Control Qual LIAISON® MUREX Anti-HDV control LIAISON® MUREX Anti-HDV LIAISON FT3 LIAISON® Biotrin Parvovirus B19 IgM Plus LIAISON® Biotrin Control Parvovirus B19 IgM Plus LIAISON(R) Control EA IgG LIAISON(R) EA IgG LIAISON XL MUREX Anti-HBs Verifiers LIAISON XL MUREX Anti-HBs LIAISON XL MUREX Control Anti-HBs LIAISON XL LIAISON Anti-HAV Control Set LIAISON Anti-HAV LIAISON XL Operating Software LIAISON® SARS-CoV-2 TrimericS IgG Control Set LIAISON® SARS-CoV-2 TrimericS IgG LIAISON Prolactin xt LIAISON Mumps IgG and LIAISON Mumps Control Set LIAISON(R) Control EBV IgM LIAISON(R) VCA IgG LIAISON(R) EBNA IgG LIAISON(R) EBV IgM LIAISON(R) Control VCA IgG LIAISO(R) Control EBNA IgG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2013-09-06
MYM	Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm	Unknown	Class 3	N/A	2019-05-07
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2013-12-03
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	1981-10-11
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2013-08-21
MYL	Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg	Unknown	Class 3	N/A	2019-05-07
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2016-03-29
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2016-03-29
OTT	Research Use Only/Microbiology	Unknown	Class N	N/A	2012-05-24
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2020-09-03
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2020-09-03
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	2023-12-07
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	2025-12-02
NCD	Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis	Unknown	Class 3	N/A	2019-12-01
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2007-12-18
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2012-09-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-09-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-01-04
CIB	Radioimmunoassay, Angiotensin I And Renin	Clinical Chemistry	Class 2	862.1085	2013-01-04
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	1981-10-11
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2013-04-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-04-09
LJB	Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	Microbiology	Class 1	866.3520	1995-03-27
OTR	Research Use Only/Immunology Devices	Unknown	Class N	N/A	2012-05-24
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2008-12-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-12-04
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	1999-01-06
NTM	Antigen, Inflammatory Response Marker, Sepsis	Microbiology	Class 2	866.3210	2018-02-28
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2018-02-28
PRI	Procalcitonin Assay	Microbiology	Class 2	866.3215	2018-02-28
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-02-28
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2007-12-18
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2021-09-17
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2020-09-03
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2020-09-03
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2020-01-31
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2020-01-31
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2017-03-21
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2017-03-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-03-21
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2007-12-18
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2007-12-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-07-01
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	1981-10-11
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
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2020-09-03
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2020-09-03
SGW	Device To Detect Antibodies To Hepatitis D Virus	Immunology	Class 2	866.3176	2026-01-02
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	1995-03-24
MYM	Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm	Unknown	Class 3	N/A	2026-06-02
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2007-12-18
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2020-02-25
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2020-02-25
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2011-01-31
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2011-01-31
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-04-25
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	1979-03-15
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	2011-04-21
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2007-12-18
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2007-12-18

Official Correspondent

Mari Meyer

US Agent Details

Mari Meyer Business: DiaSorin Inc. Email: Mari.meyer@diasorin.com Phone: (651) 4939971

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
3008576040	DiaSorin Italia S.p.A UK Branch	Dartford Kent, GB
3004434309	DiaSorin Deutschland GmbH	Dietzenbach Hesse, DE
2182595	DIASORIN INC.	Stillwater, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K954575	Abbott Laboratories	AXSYM TOXO IGG ANTIBODY ASSAY	1996-08-16
K032162	Beckman Coulter, Inc.	ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY	2003-08-08
K880678	Ventrex Laboratories, Inc.	MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY	1988-04-05
K072500	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE/SERUM TEST	2009-04-21
K222850	Abbott Laboratories	HAVAb IgG II	2023-08-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-06	Nichols Institute Diagnostics	2	Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)
Z-0007-06	Nichols Institute Diagnostics	2	Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
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-0032-2014	Bio-Rad Laboratories	2	FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Z-0102-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610240. Last updated year: 2026. Please use registration number 9610240 when referencing this establishment in official correspondence.