Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003453957

FEI Number

3003453957

Entity Name

TECHNOCLONE

City/State/Country

Vienna Wien, AT

Establishment Address

Brunner Strase 67, Vienna Wien 1230, AT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Technoclone Herstellung v. Diagnostika u. Arzneimitteln GmbH (Owner Number: 10031758)

Owner / Operator Contact Address

Brunner Str. 67, Vienna, AT-9 1230, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DG Clean

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCB	Detergent	Pathology	Class 1	864.4010	2020-02-19
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2010-03-05
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2010-03-05
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2010-03-05

Official Correspondent

Veronika Binder

US Agent Details

Jennifer Kiblinger Business: Diapharma Group, Inc. Email: JKiblinger@diapharma.com Phone: (513) 8609324

Related Public Records

Same Entity

Technoclone Herstellung v. Diagnostika u. Arzneimitteln 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
K021022	Instrumentation Laboratory CO	HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)	2002-05-14
K113211	Instrumentation Laboratory CO	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	2012-01-04
K082859	Instrumentation Laboratory CO	HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED	2008-12-19
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0514-2014	Instrumentation Laboratory Co.	2	HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014	Instrumentation Laboratory Co.	2	HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014	Instrumentation Laboratory Co.	2	HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

Similar Registrations

Registration Number	Establishment Name	Location
3007268782	MicroCare CT - John Downey	New Britain, CT, US
1000206206	TECHNOGENETICS SPA	LODI, IT
3011558129	Avantor Performance Materials Poland S.A.	Gliwice Slaskie, PL
3016438761	ABBOTT LABORATORIES	Irving, TX, US
3002809144	ABBOTT GmbH	Wiesbaden Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003453957. Last updated year: 2026. Please use registration number 3003453957 when referencing this establishment in official correspondence.