Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006644620

FEI Number

3006644620

Entity Name

DIASYS DIAGNOSTIC SYSTEMS GMBH

City/State/Country

Holzheim Rhineland-Palatinate, DE

Establishment Address

ALTE STRASSE 9, Holzheim Rhineland-Palatinate D-65558, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

DIASYS DIAGNOSTIC SYSTEMS GMBH (Owner Number: 9105042)

Owner / Operator Contact Address

ALTE STRASSE 9, --, HOLZHEIM, RHEINLAND-PFALZ, DE-NOTA D-65558, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DiaSys TruLab Procalcitonin Bi-Level Controls DiaSys Procalcitonin FS Assay DiaSys TruCaI Procalcitonin Calibrator Set ?-Hydroxybutyrate 21 Tri-Level Controls ?-Hydroxybutyrate 21 Bi-Level Controls Atellica CH Triglycerides_2 ?-Hydroxybutyrate 21 Linearity Standards Atellica CH Bilirubin Calibrator ?-Hydroxybutyrate 21 FS

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	2025-07-23
PTF	Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission	Microbiology	Class 2	866.3215	2025-07-23
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-09-17
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2007-08-07
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2018-09-17
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2018-09-17

Official Correspondent

No official correspondent registered.

US Agent Details

Stephen Gorski Business: Imagenix, Inc. Email: stephengorski@me.com Phone: (414) 7374596

Related Public Records

Same Entity

DIASYS DIAGNOSTIC SYSTEMS GMBH

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

View Entity Profile →

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-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)

Similar Registrations

Registration Number	Establishment Name	Location
3007652384	MICROBIX	Mississauga Ontario, CA
3014353121	VIDAN DIAGNOSTICS, LLC	San Antonio, TX, US
3008514395	Telcare, LLC	Linwood, PA, US
3012118659	ASCENSIA DIABETES CARE HOLDINGS AG	Basel Basel-Stadt, CH
1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006644620. Last updated year: 2026. Please use registration number 3006644620 when referencing this establishment in official correspondence.