Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610824

FEI Number

3002806595

Entity Name

BIO-RAD MEDICAL DIAGNOSTICS GMBH

City/State/Country

DREIEICH Hesse, DE

Establishment Address

Industrie Str. 1, DREIEICH Hesse 63303, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DiaMed GmbH (Bio-Rad Laboratories) (Owner Number: 10032616)

Owner / Operator Contact Address

Pra Rond 23, Cressier, CH-FR 1785, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK210625

PMA Number

N/A

All Registered Proprietary Names

MLB2 IH-1000 IH-Card Control Erytype S Rh Donor Erytype S Rh Donor Confirmation MLB 2 Solidscreen II Solidscreen II Negative Control Solidscreen II Control Erytype S ABO Donor Bromelin Bromelin for Erytype Solidscreen II Strip Negative Control Erytype S ABO Donor Confirmation Erytype S ABD+Rev. A1,B IH-Incubator L IH-500 IH-Centrifuge L IH-Papain IH-LISS Solution IH-Titration Solution IH-LISS Rack IH-Titration Rack IH-Reader 24 Washing Solution Concentrate Alsevers Solution Solidscreen II Negative Control Solidscreen II Control B Erytype S Rh+K Type IH-Card Neutral Coombscell-E MLB2 Seraclone Control ABO+Rh IH-Card ABO Neutral

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2014-01-13
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2021-02-08
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2016-11-21
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2010-06-01
PBC	Manual Blood Grouping And Antibody Test Systems	Hematology	Class 2	864.9175	2018-01-03
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2023-08-14
PBC	Manual Blood Grouping And Antibody Test Systems	Hematology	Class 2	864.9175	2018-01-03
KSK	Solution, Stabilized Enzyme	Hematology	Class 2	864.9400	2018-01-03
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2016-11-21
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2018-11-16
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2016-01-12
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2010-06-01
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2016-11-21
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2010-06-01
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2022-03-03

Official Correspondent

Jeremy Poropane

US Agent Details

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

Related Public Records

Same Entity

DiaMed GmbH (Bio-Rad Laboratories)

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004910133	DiaMed GmbH	Cressier Fribourg, CH

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610824. Last updated year: 2026. Please use registration number 9610824 when referencing this establishment in official correspondence.