Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004434309

FEI Number

3004434309

Entity Name

DiaSorin Deutschland GmbH

City/State/Country

Dietzenbach Hesse, DE

Establishment Address

Von-Hevesy-Str. 3, Dietzenbach Hesse 63128, DE

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 TSH LIAISON LH LIAISON FT3 LIAISON C-Peptid LIAISON Prolactin xt LIAISON® XL HCG HUMAN GROWTH HORMONE LIAISON hGH LIAISON hGH control set LIAISON IGF-1 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 Control Thyroid 1, LIAISON Control Thyroid 2, LIAISON Control Thyroid 3 LIAISON FT4 LIAISON Control Ferritin LIAISON Ferritin LIAISON Ferritin Calibration Verifiers S100B ELISA TK-REA LIAISON NSE LIAISON TK LIAISON Insulin LIAISON Insulin Control Set LIAISON Endocrinology Diluent 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

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	2013-04-09
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2013-04-09
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	1981-10-11
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	1995-03-24
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	1982-09-13
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	1979-03-15
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
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
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
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2021-09-17
OTR	Research Use Only/Immunology Devices	Unknown	Class N	N/A	2012-05-24
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	1979-03-15
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2010-06-24

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
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
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-0022-2025	Qualigen Inc	2	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020	Roche Diagnostics Operations, Inc.	2	AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Centaur XPT Immunoassay System
Z-0006-06	Nichols Institute Diagnostics	2	Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004434309. Last updated year: 2026. Please use registration number 3004434309 when referencing this establishment in official correspondence.