Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043379

FEI Number

3003413192

Entity Name

STRATEC SE

City/State/Country

BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg, DE

Establishment Address

GEWERBESTRASSE 37, BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg 75217, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

STRATEC SE (Owner Number: 9001219)

Owner / Operator Contact Address

GEWERBESTRASSE 37, --, BIRKENFELD, GRAEFENHAUSEN, BW, DE-BW 75217, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

InviGenius® InviGenius® PLUS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2019-04-11
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2022-08-17
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2011-02-11
PER	Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis	Clinical Chemistry	Class 1	862.2750	2020-12-18
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2011-07-25
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2013-04-04
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2020-04-30
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2021-01-06
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2014-09-18
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2020-01-27
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2012-05-15

Official Correspondent

VOLKER SCHWAAB

US Agent Details

Frank Matuszak Business: Diatron US Inc. Email: Frank.Matuszak@Diatron.com Phone: (833) 2287931

Related Public Records

Same Entity

STRATEC SE

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
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-0009-2025	Becton, Dickinson and Company, BD Bio Sciences	1	BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.

Similar Registrations

Registration Number	Establishment Name	Location
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
3016014873	BIO-RAD MEDICAL LABORATORIES LOGISTIK GMBH	Grosskugel /Kabelsketal Saxony-Anhalt, DE
2032600	Grifols Diagnostic Solutions Inc.	SAN DIEGO, CA, US
3002772505	DIAGNOSTIC GRIFOLS, S.A.	PARETS DEL VALLES Barcelona, ES
3004910133	DiaMed GmbH	Cressier Fribourg, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043379. Last updated year: 2026. Please use registration number 8043379 when referencing this establishment in official correspondence.