Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016014873

FEI Number

3016014873

Entity Name

BIO-RAD MEDICAL LABORATORIES LOGISTIK GMBH

City/State/Country

Grosskugel /Kabelsketal Saxony-Anhalt, DE

Establishment Address

Eschenallee 5, Grosskugel /Kabelsketal Saxony-Anhalt 06184, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Bio-Rad Laboratories (Bio-Rad Services France) (Owner Number: 10078397)

Owner / Operator Contact Address

Rue Gustave Eiffel, MITRY-MORY, FR-IDF 77290, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK150327

PMA Number

N/A

All Registered Proprietary Names

Erytype S Rh+K Type Solidscreen II Control B Solidscreen II Negative Control Alsevers Solution Coombscell-E Seraclone Control ABO+Rh MLB 2 IH-Papain IH-Card Neutral Wash Solution A Concentrate MLB 2 Erytype S ABD+Rev. A1,B Negative Control Bromelin for Erytype Solidscreen II Control MLB 2 Solidscreen II Solidscreen II Negative Control Solidscreen II Strip Bromelin Erytype S ABO Donor Erytype S ABO Donor Confirmation Erytype S Rh Donor Confirmation Erytype S Rh Donor IH-Internal QC Washing Solution Concentrate

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	2020-10-21
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2020-10-21
KSK	Solution, Stabilized Enzyme	Hematology	Class 2	864.9400	2024-01-17
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2020-10-21
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2024-01-17
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2020-10-21
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2020-10-21
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2024-01-17
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2024-01-17

Official Correspondent

Lucie Watremetz

US Agent Details

David Bhend Business: Bio-Rad Laboratories Email: david_bhend@bio-rad.com Phone: (425) 4981758

Related Public Records

Same Entity

Bio-Rad Laboratories (Bio-Rad Services France)

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3035708936	Bio-Rad Service France SAS	Mitry Mory Ile-de-France, FR

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8043379	STRATEC SE	BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg, DE
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 3016014873. Last updated year: 2026. Please use registration number 3016014873 when referencing this establishment in official correspondence.