Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2182595

FEI Number

2182595

Entity Name

DIASORIN INC.

City/State/Country

Stillwater, MN, US

Establishment Address

1951 Northwestern Ave, Stillwater, MN 55082, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,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

K192586

PMA Number

N/A

All Registered Proprietary Names

LIAISON XL 1,25 Dihydroxyvitamin D Controls LIAISON® MeMed BV® Calibration Verifiers 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® 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 ROTAVIRUS LIAISON ROTAVIRUS Control set LIAISON Calcitonin II Gen LIAISON Calcitonin II Gen Control Set LIAISON Progesterone II Gen Control Set LIAISON Progesterone II Gen LIAISON Q.S.E.T. Buffer LIAISON Calprotectin LIAISON Q.S.E.T. Device LIAISON Calprotectin Control Set LIAISON Calprotectin Calibration Verifiers LIAISON Q.S.E.T. Device Plus LIAISON BAP OSTASE LIAISON BAP OSTASE Control Set LIAISON Lyme IgM Control LIAISON Lyme Total Antibody Plus LIAISON Lyme IgM LIAISON XL 1,25 Dihydroxyvitamin D LIAISON XL 1,25 Dihydroxyvitamin D Calibration Verifiers LIAISON HSV-2 Type Specific IgG LIAISON Control HSV-2 IgG LIAISON® EBV IgM Serum Control Set LIAISON(R) Borrelia burgdorferi Ser LIAISON(R) Borrelia burgdorferi LIAISON XL Zika Capture IgM II Control Set LIAISON XL Zika Capture IgM II LIAISON® Adenovirus Control Set LIAISON® Adenovirus LIAISON Osteocalcin LIAISON Osteocalcin control set LIAISON Q.S.E.T Device LIAISON Q.S.E.T. Device Plus LIAISON Calprotectin S100B ELISA TK-REA LIAISON NSE LIAISON TK LIAISON C. DIFFICILE GDH CONTROL SET LIAISON C. DIFFICILE GDH LIAISON C. Difficile Toxins A&B Control Set LIAISON C. Difficile Toxins A&B nDNA Fluoro-Kit 100 (Crithidia luci nDNA Fluoro-Kit 50 (Crithidia lucil LIAISON Lyme IgG Control set LIAISON Lyme Total Antibody Plus LIAISON Lyme IgG LIAISON IQ Reader LIAISON 1-84 AldoCTK - RIA LIAISON BAP OSTASE LIAISON HSV-1 Type Specific IgG LIAISON Control HSV-1 IgG LIAISON Lyme Total Antibody Plus LIAISON Lyme Total Antibody Plus Control Set LIAISON 25 OHD TOTAL Cal Verifiers LIAISON Campylobacter Ag Control Set LIAISON Campylobacter Ag LIAISON 1-84 PTH Control Set LIAISON 1-84 PTH Assay LIAISON 1-84 PTH Cal Verifiers LIAISON 1-84 PTH Specimen Diluent LIAISON SHBG LIAISON SHBG Control Set COMPLEMENT ACTIVATION EIA (CAE) KIT LIAISON Endocrinology Calibration Verifiers 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 H. pylori IgG LIAISON H. pylori IgG Control Set LIAISON Folate Control Set LIAISON Folate Calibration Verifiers LIAISON Folate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-02-19
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
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2010-06-24
LIQ	Enzyme Linked Immunoabsorbent Assay, Rotavirus	Microbiology	Class 1	866.3405	2014-05-02
JKR	Radioimmunoassay, Calcitonin	Clinical Chemistry	Class 2	862.1140	2012-05-07
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	1991-04-29
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-01-09
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2019-01-09
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	Clinical Chemistry	Class 2	862.1050	2014-05-02
QCH	Assayed Quality Control Material For Clinical Microbiology Assays	Microbiology	Class 2	866.3920	2021-02-18
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2021-02-18
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-01-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-01-04
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2013-01-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-12-11
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2014-12-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-12-04
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	Microbiology	Class 2	866.3305	2008-12-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-07-01
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2007-12-19
QFO	Zika Virus Serological Reagents	Microbiology	Class 2	866.3935	2019-11-01
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	1999-01-06
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2015-03-23
NEO	System, Test, Osteocalcin	Clinical Chemistry	Class 2	862.1050	2014-05-02
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-01-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-01-04
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2022-08-08
OTR	Research Use Only/Immunology Devices	Unknown	Class N	N/A	2012-05-24
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-01-04
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2013-01-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-01-04
MCB	Antigen, C. Difficile	Microbiology	Class 1	866.2660	2012-05-08
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2007-12-19
QCH	Assayed Quality Control Material For Clinical Microbiology Assays	Microbiology	Class 2	866.3920	2021-02-18
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2021-02-18
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2021-04-14
OTV	Research Use Only/Clinical Chemistry Devices	Unknown	Class N	N/A	2012-05-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-12-04
MXJ	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	Microbiology	Class 2	866.3305	2008-12-04
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2020-02-03
QCH	Assayed Quality Control Material For Clinical Microbiology Assays	Microbiology	Class 2	866.3920	2020-02-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-10-12
LQP	Campylobacter Spp.	Microbiology	Class 1	866.3110	2016-11-28
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2015-06-23
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-06-23
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2017-04-27
DAE	Complement C9, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2016-01-28
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2019-08-20
NCD	Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis	Unknown	Class 3	N/A	2019-12-01
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2016-07-26
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2016-07-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-07-26
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2020-05-07

Official Correspondent

Mari Meyer

US Agent Details

No US Agent registered (Local establishment).

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
9610240	DiaSorin Italia S.p.A.	SALUGGIA Vercelli, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
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 2182595. Last updated year: 2026. Please use registration number 2182595 when referencing this establishment in official correspondence.