Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004910133

FEI Number

3004910133

Entity Name

DiaMed GmbH

City/State/Country

Cressier Fribourg, CH

Establishment Address

Pra Rond 23, Cressier Fribourg 1785, CH

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

BK190424

PMA Number

N/A

All Registered Proprietary Names

TANGO infinity IH-Basic QC IH-Incubator L Washing Solution Concentrate IH-500 Coombscell-E MLB2 Seraclone Control ABO+Rh Wash Solution A Concentrate 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-Reader 24 Alsevers Solution Solidscreen II Negative Control Solidscreen II Control B Erytype S Rh+K Type IH-LISS Solution IH-Titration Solution IH-LISS Rack IH-Titration Rack IH-Papain IH-Card ABO Neutral IH-Com

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	2020-01-29
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2018-01-03
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	2016-01-12
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2023-08-14
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2010-06-01
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2020-01-24
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	2018-11-16
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2010-06-01
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2016-11-21
KSK	Solution, Stabilized Enzyme	Hematology	Class 2	864.9400	2018-01-03
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2022-03-03
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2021-02-15

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
9610824	BIO-RAD MEDICAL DIAGNOSTICS GMBH	DREIEICH Hesse, DE

Similar Registrations

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2032600	Grifols Diagnostic Solutions Inc.	SAN DIEGO, CA, US
8043379	STRATEC SE	BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg, DE
3002772505	DIAGNOSTIC GRIFOLS, S.A.	PARETS DEL VALLES Barcelona, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004910133. Last updated year: 2026. Please use registration number 3004910133 when referencing this establishment in official correspondence.