Quality Management Systems Certificates

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Design Center and Manufacturing Certificates

 

Americas

Number

Type

Location

Expiry Date

 

ISO 13485:2016

Brazil

February 07, 2025

Site Address

DiaMed Latino America S.A. Rua Alfredo Albano da Costa, 100 Lagoa Santa Mias Gerais 33240-095 Brasil

 

Facility Type

Manufacturing for Immunohematology products distributed in Brazil

Products

In vitro diagnosis in the field of immunohematology and serology

 

QMS Scope

Production and distribution of In vitro reagents and distribution, installation, training, and service for In vitro instruments for immunohematology.

ISO 13485:2016

USA

July 8, 2024

Site Address

2000 Alfred Nobel Drive, Hercules, CA 94547, USA

925 Alfred Nobel Drive, Hercules, CA 94547, USA

2500 Atlas Rd, Richmond, CA 94806, USA

487 Aviation Blvd., #100, Santa Rosa, CA 95403, USA

3110 Regatta Blvd, Richmond, CA 94804, USA

6000 James Watson, Hercules, CA 94547, USA

 

Facility Type

Design Centre for Life Science Products & Manufacturing for Life Science and Digital Biology Products

Products

Life Science (Protein Separation, Gene Expression, Process Chromatography), Digital Biology

 

QMS Scope

The design, development, manufacture, and distribution of reagents and analytical instruments. The installation and servicing of analytical instruments

ISO 13485:2016

USA

August 11, 2025

Site Address

Bio-Rad Laboratories, Inc., 5731 W. Las Positas Blvd, Pleasanton, CA 94588, United States

 

Facility Type

Design Centre for Digital Biology Products

Products

All ddPCR products (QX200, ddSEQ, QXDx, QX One)

 

QMS Scope

Design and development, manufacture and distribution of digital polymerase chain reaction (PCR) systems used for the management of residual cancer markers, and management of disease status.

ISO 13485: 2016 & MDSAP

USA

August 11, 2025

Site Address

Bio-Rad Laboratories, Inc., 5731 W. Las Positas Blvd, Pleasanton, CA 94588, United States

 

Facility Type

Design Centre for Digital Biology Products

Products

All ddPCR products (QX200, ddSEQ, QXDx, QX One)

 

QMS Scope

Design and development, manufacture and distribution of digital polymerase chain reaction (PCR) systems used for the management of residual cancer markers, and management of disease status.

NF EN ISO 13485:2016

USA

August 11, 2025

Site Address

Bio-Rad Laboratories, Inc., 5731 W. Las Positas Blvd, Pleasanton, CA 94588, United States

 

Facility Type

Design Centre for Digital Biology Products

Products

All ddPCR products (QX200, ddSEQ, QXDx, QX One)

 

QMS Scope

Design and development, manufacture and distribution of digital polymerase chain reaction (PCR) systems used for the management of residual cancer markers, and management of disease status.

ISO 13485:2016

USA

July 17, 2025

Site Address

Bio-Rad Laboratories, Inc. - Seattle Operations, 6565 185th Avenue NE - Redmond - WA - 98052 - USA

Bio-Rad Laboratories, Inc. - Seattle Operations, 14620 NE N Woodinville Way - Suite 200 - Woodinville - WA 98072 - 8440 - USA

Bio-Rad Laboratories, Inc. - Seattle Operations, 8415 - 216th Street SE - Woodinville - WA 98072 - USA

 

Facility Type

Manufacturing for Clinical Diagnostics Products

Products

In vitro diagnostic test kits and reagents used in donor screening; diagnosis of diseases caused by transmissible agents and sexually transmissible agents; and the monitoring/diagnosis of endocrine disorders, immune, and autoimmune diseases.

 

QMS Scope

Design and development, manufacture and distribution of, in-vitro diagnostic test kits and in-vitro diagnostic reagents used in donor screening, the diagnosis of diseases caused by transmissible agents and sexually transmissible agents and the monitoring/diagnosis of endocrine disorders, immune and autoimmune disorders.

ISO 13485: 2016 & MDSAP

USA

July 17, 2025

Site Address

Bio-Rad Laboratories, Inc. - Seattle Operations, 6565 185th Avenue NE, Redmond, WA-98052, USA

Bio-Rad Laboratories, Inc. - Seattle Operations, 14620 NE N Woodinville Way, Suite 200, Woodinville, WA 98072 - 8440, USA

Bio-Rad Laboratories, Inc. – Seattle Operations, 8415 216th Street SE, Woodinville, WA 98072 - 8440, USA

 

Facility Type

Manufacturing for Clinical Diagnostics Products

Products

In vitro diagnostic test kits and reagents used in donor screening; diagnosis of diseases caused by transmissible agents and sexually transmissible agents; and the monitoring/diagnosis of endocrine disorders, immune, and autoimmune diseases.

 

QMS Scope

Design and development, manufacture and distribution of, in-vitro diagnostic test kits and in-vitro diagnostic reagents used in donor screening, the diagnosis of diseases caused by transmissible agents and sexually transmissible agents and the monitoring/diagnosis of endocrine disorders, immune and autoimmune disorders.

ISO 13485: 2016 & MDSAP

USA

December 20, 2024

Site Address

Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Drive, Hercules, CA 94547, USA

Bio-Rad Laboratories, Inc., 800 Alfred Nobel Drive, Hercules, CA 94547, USA

Bio-Rad Laboratories, Inc., 5500 East Second Street, Benicia, CA 94510, USA

1 Kaki Bukit View #03-01, 415941 Techview, Republic of Singapore

 

Facility Type

Design centre for Clinical Immunology and Diabetes, & Manufacturing for Clinical Diagnostics and Digital Biology Products

Products

EIA and IFA kits / reagents for autoimmune disease testing; BioPlex system and associated kits / reagents for serology, autoimmune, and infectious disease testing; Instruments and kits / reagents for diabetes, hemoglobin variant testing; IVD test kits for drugs of abuse, test kits / reagents for special chemistry testing

 

QMS Scope

Design and development, manufacture and distribution of in-vitro diagnostic test kits and in-vitro diagnostic analyzer / software used for serology and special chemistry, diagnosis of diseases caused by transmissible agents and sexually transmissible agents and diagnosis and/or monitoring of hemoglobin variants, diabetes, autoimmune diseases, genetic disorders and toxicology, including drug of abuse.

ISO 13485:2016

USA

December 20, 2024

Site Address

Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Drive, Hercules, CA 94547, USA

Bio-Rad Laboratories, Inc., 800 Alfred Nobel Drive, Hercules, CA 94547, USA

Bio-Rad Laboratories, Inc., 5400 East Second Street, Benicia, CA 94510, USA

Bio-Rad Laboratories, Inc., 5500 East Second Street, Benicia, CA 94510, USA

 

Facility Type

Design centre for Clinical Immunology and Diabetes, & Manufacturing for Clinical Diagnostics and Digital Biology Products

Products

EIA and IFA kits / reagents for autoimmune disease testing; BioPlex system and associated kits / reagents for serology, autoimmune, and infectious disease testing; Instruments and kits / reagents for diabetes, hemoglobin variant testing; IVD test kits for drugs of abuse, test kits / reagents for special chemistry testing

 

QMS Scope

Design and development, manufacture and distribution of in-vitro diagnostic test kits and in-vitro diagnostic analyzer / software used for serology and special chemistry, diagnosis of diseases caused by transmissible agents and sexually transmissible agents and diagnosis and/or monitoring of hemoglobin variants, diabetes, autoimmune diseases, genetic disorders and toxicology, including drug of abuse.

ISO 13485:2016

USA

May 17, 2025

Site Address

9500 Jeronimo Road, Irvine, CA 92618, USA

9 Holland Drive, Irvine, CA 92618, USA

21 Technology Drive, Irvine, CA 92618, USA

9560 Jeronimo Road, Irvine, CA 92618, USA

 

Facility Type

Design Centre & Manufacturing for Quality Controls

Products

Quality Controls and related Software and EQAS

 

QMS Scope

Design, development, manufacturing, distribution and technical support of in vitro diagnostic medical devices for clinical laboratory quality control programs.

ISO 13485: 2016 & MDSAP

USA

May 17, 2025

Site Address

9500 Jeronimo Road, Irvine, CA 92618, USA

9 Holland Drive, Irvine, CA 92618, USA

21 Technology Drive, Irvine, CA 92618, USA

9560 Jeronimo Road, Irvine, CA 92618, USA

 

Facility Type

Design Centre & Manufacturing for Quality Controls

Products

Quality Controls and related Software and EQAS

 

QMS Scope

Design, development, manufacturing, distribution and technical support of in vitro diagnostic medical devices for clinical laboratory quality control programs.

ISO 13485:2016

USA

June 10, 2023

Site Address

1045 Riverside Street, Portland, ME 04103, USA

 

Facility Type

Manufacturing for Raw Materials for Quality Controls and Cell Culture Services

Products

Raw Materials Reagents and Cell Culture Services

 

QMS Scope

Development, Manufacture and Distribution of critical Raw Materials for in-vitro Diagnostic Reagents and Cell Culture Services

ISO 13485:2016

USA

May 26, 2026

Site Address

100 South Jones Street, Suite 100, Fort Worth, Texas 76104, USA

 

Facility Type

Design Centre & Manufacturing for Molecular Quality Controls

Products

Quality control materials for molecular testing

 

QMS Scope

Development and manufacture of In Vitro Diagnostic and Research Use Only quality control materials for molecular testing

ISO 27001:2013

USA

February 2, 2025

Site Address

Alfred Nobel Drive 1000, Hercules, CA 94547 United States

 

Facility Type

N/A

Products

N/A

 

QMS Scope

N/A

Asia Pacific

Number

Type

Location

Expiry Date

 

MDSAP

Singapore

December 20, 2024

UKAS ISO 13485:2016
UKAS EN ISO 13485:2016

Singapore

June 20, 2026

SAC ISO 13485:2016

Singapore

June 20, 2026

Europe, Middle East and Africa

Number

Type

Location

Expiry Date

 

ISO 13485:2016

France

December 11, 2024

Site Address

BIO-RAD, 3 Bd Raymond Poincare, 92430 Marnes La Coquette, France

BIO-RAD, Route de Cassel, 59114 Steenvoorde, France

BIO-RAD, 7 Rue de Madrid, 67300, Schiltigheim, France

BIO-RAD, 18 Avenue du Polygone, 42300 Roanne, France

 

Facility Type

Design Centre & Manufacturing for Clinical Diagnostics Products (Infectious Disease)

Products

In vitro diagnostic test kits and reagents used in diagnosis of diseases caused by transmissible agents and sexually transmissible agents; and the monitoring/diagnosis of endocrine disorders, immune, and autoimmune diseases.

 

QMS Scope

The design/development, production and contract manufacturing of reagents, instruments and software for in vitro diagnostics medical devices and alternative methods for detection of micro-organisms. (Marnes la Coquette, Steenvoorde, Schiltgheim, Roanne). Manufacturing, control and sale of parts for medical devices and plastic-molded products. (Boissy-L'Aillerie).

ISO 9001:2015

France

October 22, 2023

Site Address

BIO-RAD PARC D’ACTIVITES DE GEMENOS, 845 AVENUE DU PIC DE BERTAGNE, 13788 GEMENOS CEDEX - FRANCE

 

Facility Type

Manufacturing site for plastic parts for In vitro diagnostic.

Products

Plastic components

 

QMS Scope

INDUSTRIALISER, FABRIQUER, ASSEMBLER, CONDITIONNER ET COMMERCIALISER DES PIECES PLASTIQUES POUR ENSEMBLE PLASTIQUE ET DISPOSITIFS MEDICAUX (FABRICATION EN SOUS-TRAITANCE)

ISO 13485:2016

France

October 22, 2023

Site Address

BIO-RAD PARC D’ACTIVITES DE GEMENOS, 845 AVENUE DU PIC DE BERTAGNE, 13788 GEMENOS CEDEX - FRANCE

 

Facility Type

Manufacturing site for plastic parts for In vitro diagnostic.

Products

Plastic components

 

QMS Scope

Industrialize, manufacture, assemble, package and market plastic parts for plastic assemblies and medical devices (subcontract manufacturing). Plastic parts for In vitro diagnostic test kits and reagents.

ISO 9001:2015

Israel

January 2, 2025

Site Address

BIO-RAD ISRAEL LTD. 14, Hahoma St. , Rishon Lezion , Israel

 

Facility Type

Design Center & Manufacturing

Products

Design and manufacturing of software for computerized analysis systems

 

QMS Scope

Design and development of software for computerized analysis systems. Sales, distribution and after sales service of bio-rad's life science and medical diagnostic products.

ISO 13485:2016

Belgium

September 5, 2024

Site Address

BIO-RAD, Begoniastraat 5, 9810 Nazareth, Belgium

Facility Type

Design Centre & Manufacturing for Clinical Diagnostics Products (Liquid Chromatography)

Products

Liquid chromatography packing materials, columns, and cartidges for In Vitro Diagnostic use.

 

QMS Scope

The design, development, and manufacturing of liquid chromatography packing materials, columns, and cartidges for In Vitro Diagnostic use.

ISO 13485: 2016 & MDSAP

France

December 11, 2024

Site Address

BIO-RAD, 3 Bd Raymond Poincare, 92430 Marnes La Coquette, France

BIO-RAD, Route de Cassel, 59114 Steenvoorde, France

BIO-RAD, 7 Rue de Madrid, 67300, Schiltigheim, France

BIO-RAD, 18 Avenue du Polygone, 42300 Roanne, France

 

Facility Type

Design Centre & Manufacturing for Clinical Diagnostics Products (Infectious Disease)

Products

In vitro diagnostic test kits and reagents used in diagnosis of diseases caused by transmissible agents and sexually transmissible agents; and the monitoring/diagnosis of endocrine disorders, immune, and autoimmune diseases.

 

QMS Scope

The design/development, production and contract manufacturing of in-vitro diagnostic test kits, reagents, instruments and software used in the diagnosis of diseases caused by infectious agents transmissible and sexually transmissible, the determination of microbial susceptibility to antibiotics, the diagnosis and monitoring of immune and auto-immune disorders and in Immuno-Hematology testing.

ISO 9001:2015
ENGLISH VERSION

Germany

January 9, 2024

Site Address

Anna-Sigmund-Str. 5, D-82061 Neuried, Germany

 

Facility Type

Design Centre & Manufacturing for Life Science Products (Antibodies)

Products

Antibodies

 

QMS Scope

Development, characterization and production of antibodies for non-therapeutic applications, in particular antibodies for research and diagnostics

ISO 9001:2015
GERMAN VERSION

Germany

January 9, 2024

Site Address

Anna-Sigmund-Str. 5, D-82061 Neuried, Germany

 

Facility Type

Design Centre & Manufacturing for Life Science Products (Antibodies)

Products

Antibodies

 

QMS Scope

Development, characterization and production of antibodies for non-therapeutic applications, in particular antibodies for research and diagnostics

ISO 13485: 2016 & MDSAP
ENGLISH VERSION

Germany

March 22, 2024

Site Address

Bio-Rad Medical Diagnostics GmbH
Industriestr 1, 63303, Dreieich, Germany

Bio-Rad Medical Diagnostics GmbH
Industriestr 4, 63303, Dreieich, Germany

Bio-Rad Medical Diagnostics GmbH
Heinrich-Hertz Strasse 1, 63303 Dreieich, Germany

Bio-Rad Medical Diagnostics GmbH
Heinrich-Hertz Strasse 3, 63303 Dreieich, Germany

 

Facility Type

Design Centre & Manufacturing for Immunohematology products

Products

Tissue compatibility testing, blood grouping, detection of infectious diseases

 

QMS Scope

Design and development, manufacture and distribution of in-vitro diagnostic medical devices used in tissue compatibility testing, blood grouping and the detection of infectious diseases

ISO 13485:2016
ENGLISH VERSION

Germany

June 8, 2024

Site Address

Bio-Rad Medical Diagnostics GmbH
Industriestr 1, 63303, Dreieich, Germany

Bio-Rad Medical Diagnostics GmbH
Industriestr 4, 63303, Dreieich, Germany

Bio-Rad Medical Diagnostics GmbH
Heinrich-Hertz Strasse 1, 63303 Dreieich, Germany

Bio-Rad Medical Diagnostics GmbH
Heinrich-Hertz Strasse 3, 63303 Dreieich, Germany

 

Facility Type

Design Centre & Manufacturing for Immunohematology products

Products

Tissue compatibility testing, blood grouping, detection of infectious diseases

 

QMS Scope

Design and development, manufacture and distribution of in-vitro diagnostic medical devices used in tissue compatibility testing, blood grouping and the detection of infectious diseases

ISO 13485:2016
GERMAN VERSION

Germany

June 8, 2024

Site Address

Bio-Rad Medical Diagnostics GmbH
Industriestr 1, 63303, Dreieich, Germany

Bio-Rad Medical Diagnostics GmbH
Industriestr 4, 63303, Dreieich, Germany

Bio-Rad Medical Diagnostics GmbH
Heinrich-Hertz Strasse 1, 63303 Dreieich, Germany

Bio-Rad Medical Diagnostics GmbH
Heinrich-Hertz Strasse 3, 63303 Dreieich, Germany

 

Facility Type

Design Centre & Manufacturing for Immunohematology products

Products

Tissue compatibility testing, blood grouping, detection of infectious diseases

 

QMS Scope

Design and development, manufacture and distribution of in-vitro diagnostic medical devices used in tissue compatibility testing, blood grouping and the detection of infectious diseases

ISO 13485: 2016 & MDSAP

Switzerland

October 2, 2024

Site Address

DiaMed GmbH, Pra Rond 23, 1785 Cressier FR, Switzerland

 

Facility Type

Design Centre & Manufacturing for Immunohematology products

Products

Products, reagents and instruments for immunohaematology in vitro Diagnostics

 

QMS Scope

Design and Development, Manufacturing and Distribution of In-Vitro Diagnostic Medical Devices for Immunhaematology, Haematology, Immunochemistry, Coagulation and Infectious Diseases

ISO 13485:2016

Switzerland

October 30, 2024

Site Address

DiaMed GmbH, Pra Rond 23, 1785 Cressier FR, Switzerland

 

Facility Type

Design Centre & Manufacturing for Immunohematology products

Products

Products, reagents and instruments for immunohaematology in vitro Diagnostics

 

QMS Scope

Design and Development, Manufacturing and Distribution of In-Vitro Diagnostic Medical Devices for Immunhaematology, Haematology, Immunochemistry, Coagulation and Infectious Diseases

ISO 9001:2015

UK

July 19, 2024

Site Address

Endeavour House, Langford Lane, Kidlington, Oxfordshire, OX5 1GE, UK

 

Facility Type

Design Centre & Manufacturing for Life Science Products (Antibodies)

Products

Antibodies

 

QMS Scope

The Design, Development, Manufacture, Supply and Support of High Quality Immunological Reagents, including Custom Products, for the Global Life Science Market

Sales Service and Distribution

Americas

Number

Type

Location

Expiry Date

 

ISO 13485:2016
ENGLISH VERSION

Canada

September 21, 2024

Site Address

2403 Guenette St., Montreal QC, H4R 2E9, Canada

1329 Meyerside Drive, Mississauga ON L5T 1C9, Canada

 

Facility Type

Sales, Service & Distribution Organization

QMS Scope

The sale, distribution, installation, and service of clinical diagnostics, life sciences reagents, instruments, and associated products.

ISO 13485:2016
FRENCH VERSION

Canada

September 21, 2024

Site Address

2403 Guenette St., Montreal QC, H4R 2E9, Canada

1329 Meyerside Drive, Mississauga ON L5T 1C9, Canada

 

Facility Type

Sales, Service & Distribution Organization

QMS Scope

The sale, distribution, installation, and service of clinical diagnostics, life sciences reagents, instruments, and associated products.

ISO 9001:2015

Mexico

September 17, 2023

Site Address

Eugenia 197 Piso 10 A, Col. Narvarte, Del. Benito Juarez, Ciudad de Mexico, CP 03020, Mexico

 

Facility Type

Sales, Service & Distribution Organization

QMS Scope

Conditioning of national and imported diagnostic products

Asia Pacific

Number

Type

Location

Expiry Date

 

ISO 9001:2015

Australia & New Zealand

November 22, 2025

Site Address

Units 1a, 62 Ferndell Street South Granville NSW 2142 Australia

189 Bush Road Albany Auckland New Zealand

 

Facility Type

Sales, Service & Distribution Organization

QMS Scope

The marketing, sale, supply, installation and service of; life science instrumentation and consumables for use in scientific research; clinical diagnostic automated test systems and test kits for detection of diseases and medical conditions for use in the healthcare market; quality control products and data management for use in clinical laboratories.

ISO 13485:2016

China

January 14, 2025

Site Address

Bio-Rad Laboratories (Shanghai) Co., Ltd
Section C, 4F, No. 15 Workshop
No. 69, Xiya Road, Shanghai Free Trade Zone
Shanghai 200131 China

Bio-Rad Laboratories (Shanghai) Co., Ltd, Branch
Room 501, 502, and 6F
No. 168, Jingzhou Raod, Yangpu District
Shanghai 200082 China

Bio-Rad Laboratories (Shanghai) Co., Ltd, Beijing Branch
Room 101, 1F, Building 20
No. 10, Jiuxiaoqiao Road, Chaoyang District
Beijing 100015 China

Bio-Rad Laboratories (Shanghai) Co., Ltd, Guangzhou Branch
Unit 02-03, 13F, No. 403, East Huanshi Road
Yuexiu District, Guangzhou
Guangdong 510095 China

Bio-Rad Laboratories (Shanghai) Co., Ltd, Wuhan Branch
Room 2008-2009, Wuhan Wuchang Wanda Center
No.96, Linjiang Avenue, Wuchang District, Wuhan
Hubei 430060 China

 

Facility Type

Sales, Service & Distribution Organization

QMS Scope

The provision of sales, after sales services, warehouse storage and logistics, labeling, unpacking and repackaging for in vitro diagnostic medical devices, in vitro diagnostic reagent.

ISO 9001:2015

China

Febuary 24, 2025

Site Address

Bio-Rad Laboratories (Shanghai) Co., Ltd
Section C, 4F, No. 15 Workshop
No. 69, Xiya Road, Shanghai Free Trade Zone
Shanghai 200131 China

Bio-Rad Laboratories (Shanghai) Co., Ltd, Branch
Room 501, 502, and 6F
No. 168, Jingzhou Raod, Yangpu District
Shanghai 200082 China

Bio-Rad Laboratories (Shanghai) Co., Ltd, Beijing Branch
Room 101, 1F, Building 20
No. 10, Jiuxiaoqiao Road, Chaoyang District
Beijing 100015 China

Bio-Rad Laboratories (Shanghai) Co., Ltd, Guangzhou Branch
Unit 02-03, 13F, No. 403, East Huanshi Road
Yuexiu District, Guangzhou
Guangdong 510095 China

Bio-Rad Laboratories (Shanghai) Co., Ltd, Wuhan Branch
Room 2008-2009, Wuhan Wuchang Wanda Center
No.96, Linjiang Avenue, Wuchang District, Wuhan
Hubei 430060 China

 

Facility Type

Sales, Service & Distribution Organization

QMS Scope

The provision of sales, after sales services, warehouse storage and logistics, labeling, unpacking and repackaging for in vitro diagnostic medical devices, in vitro diagnostic reagent and consumable. The provision of sales, after sales services, warehouse storage and logistics for laboratory devices, reagent and consumable.

ISO 9001:2015

India

March 9, 2026

Site Address

9th Floor, Tower A, EMAAR,Digital Greens, Sector-61, Golf, Course Extension, Gurgaon, Haryana 122102, India.

Third Floor, Unit No. 304, Brigade Rubix Plot No MYS, 357, Peenya Plantation, Bangalore North Taluk, HMT Factory Main Road, Yeshwanthpur, Bengaluru (Bangalore), Urban, Karnataka 560013, India

3rd Floor, Super Area, Tower A, DLF IT Park-I, Kolkata, West Bengal, 700163, India

Hiranandani Business Park, 4, 402, Quantum, Ghodbunder Road, Hiranandani Estate, Thane, Maharashtra, 400607, India

Ground Floor, C1, Anmol Palani No-88, G.N.Chetty Road,T.Nagar, Chennai, Tamil Nadu 600017, India

Door no. 116, C/o. Expeditors International Pvt. Ltd, Devaneri Village Road, Sholavaram Village, Chennai, Tamilnadu 600067, India

 

Facility Type

Sales, Service & Distribution Organization

QMS Scope

Import, Export, Service & Trade in Electronic Software, Hardware Equipment, Reagent, Kits, Chemicals, Consumables, Informatics products and Allied Products for Life Science Research, Clinical Diagnostics and Informatics

ISO 9001:2015

Singapore

July 3, 2024

Site Address

3A International Business Park, ICON@IBP Tower B #11-10/16, Singapore 609935

30 Toh Guan Road #03-00/01 Singapore 608840

 

Facility Type

Sales, Service & Distribution Organization

QMS Scope

Marketing, Sales, Distribution and Service of Life Science Consumables, Equipment and Clinical Diagnostic Products

SS 620:2016 GDP

Singapore

October 5, 2024

Site Address

UPS SCS (SINGAPORE) PTE LTD, 31 Alps Avenue. Level 3, SIngapore 498784

3A International Business Park, ICON@IBP Tower B #11-10/16, Singapore 609935

30 Toh Guan Road #03-00/01 Singapore 608840

Kuehne + Nagel PTE Ltd, 10 Pioneer Crescent, Singapore Logistic Hub, Singapore 628566

 

Facility Type

Sales, Service & Distribution Organization

QMS Scope

Import, storage, distribution (including transportation), installation, servicing (including repair/maintenance) of electro mechanical medical devices, single-use devices, in vitro diagnostic devices and medical software (Special Storage and Handling Conditions at 2–8° C and below –20° C)

Europe, Middle East and Africa

Number

Type

Location

Expiry Date

 

ISO 9001:2015

Czech Republic

June 15, 2024

Site Address

Pikrtova 1737/1a, 140 00 Praha, Ceska republika

 

Facility Type

Sales & Service Organization

QMS Scope

Wholesale of Clinical Diagnostics, Health Instruments and Products "Life Science" and Service of Health Instruments.

ISO 9001:2015 CZECH VERSION

Czech Republic

June 15, 2024

Site Address

Pikrtova 1737/1a, 140 00 Praha, Ceska republika

 

Facility Type

Sales & Service Organization

QMS Scope

Wholesale of Clinical Diagnostics, Health Instruments and Products "Life Science" and Service of Health Instruments.

ISO 13485:2016

Europe Distribution (France & Germany)

June 21, 2026

Site Address

Bio-Rad Laboratories Logistik GmbH, European Distribution Center East (EDCE), Eschenallee 5, 06184 Grosskugel-Kabelsketal, Germany

Bio-Rad Service France, European Distribution Center West (EDCW), Rue des Freres Lumiere, 77290 Mitry Mory, France

 

Facility Type

Distribution Center

QMS Scope

Distribution of products, instruments and reagents and instrument service for in-vitro-diagnostic

ISO 9001:2015
HUNGARIAN VERSION

Hungary

December 3, 2023

Site Address

1082 Budapest, Futo u. 47-53

 

Facility Type

Sales & Service Organization

QMS Scope

Trading, scientific and application support of in vitro diagnostic and other devices, instruments and reagents; providing technical service of sold devices and instruments.

ISO 9001:2015
ENGLISH VERSION

Hungary

December 3, 2023

Site Address

1082 Budapest, Futo u. 47-53

 

Facility Type

Sales & Service Organization

QMS Scope

Trading, scientific and application support of in vitro diagnostic and other devices, instruments and reagents; providing technical service of sold devices and instruments.

ISO 9001:2015

Northern Europe, France, Central Europe & Southern Europe

August 25, 2024

Site Address

Bio-Rad Laboratories BV, Kauwenhoven 78, 6741 PW Lunteren Netherlands 6741 PW, The Netherlands

Bio-Rad Laboratories Ltd, The Junction 3rd and 4th Floor, Station Road, Watford, WD17 1ET, UK

Bio-Rad Laboratories BV, Winninglaan 3, Temse, B-9140, Belgium

Bio-Rad Laboratories AB, Solna Strandvag 3, Solna, 171 54, Sweden

Bio-Rad Norway AS, Torgbygget, Nydalsveien 33, Oslo, NO-0421, Norway

Bio-Rad Finland OY, Kutomotie 16, 00380 Helsinki, Finland

Bio-Rad Denmark Aps, Symbion Science Park, Fruebjergvej 3, Kobenhavn O, DK-2100, Denmark

DiaMed Benelux NV, Winninglaan 3, Temse, B-9140, Belgium

Bio-Rad France, 3 Boulevard Raymond Poincare, Marnes La Coquette, 92430, France

Bio-Rad France, Rue des Freres Lumiere, Mitry-Mory, 77290, France

Bio-Rad Laboratories GmbH Kapellenstrasse 12 85622 Feldkirchen Germany

DiaMed Diagnostika Deutschland GmbH Kapellenstrasse 12 85622 Feldkirchen Germany

Bio-Rad Laboratories Ges.m.b.H Am Europlatz 2 1120 Wien Austria

Bio-Rad Laboratories AG Pra Rond 23 1785 Cressier FR Switzerland

Bio-Rad Laboratories S.A. Ed. "M" Miniparc II, C/Calendula 95, Alcobendas (Madrid) Spain

Bio-Rad Laboratories S.r.l. Via Cellini 18/A Segrate (Milan), Italy

Bio-Rad Laboratories Lda Torre Monsanto Rua Afonso Praca 30, Algés (Lisbon), Portugal

 

Facility Type

Sales & Service Organization

QMS Scope

Sales, technical support and after-sales service of life science research products and in vitro diagnostic medical devices.

ISO 13485:2016

Northern Europe, France, Central Europe & Southern Europe

September 1, 2024

Site Address

Bio-Rad Laboratories BV, Kauwenhoven 78, 6741 PW Lunteren Netherlands 6741 PW, The Netherlands

Bio-Rad Laboratories Ltd, The Junction 3rd and 4th Floor, Station Road, Watford, WD17 1ET, UK

Bio-Rad Laboratories AB, Solna Strandvag 3, Solna, 171 54, Sweden

Bio-Rad Norway AS, Torgbygget, Nydalsveien 33, Oslo, NO-0421, Norway

Bio-Rad Finland OY, Kutomotie 16, 00380 Helsinki, Finland

Bio-Rad Denmark Aps, Symbion Science Park, Fruebjergvej 3, Kobenhavn O, DK-2100, Denmark

DiaMed Benelux NV, Winninglaan 3, Temse, B-9140, Belgium

Bio-Rad Laboratories SA-NV, Winninglaan 3, Temse, B-9140, Belgium

Bio-Rad France, 3 Boulevard Raymond Poincare, Marnes La Coquette, 92430, France

Bio-Rad France, Rue des Freres Lumiere, Mitry-Mory, 77290, France

Bio-Rad Laboratories GmbH Kapellenstrasse 12 85622 Feldkirchen Germany

DiaMed Diagnostika Deutschland GmbH Kapellenstrasse 12 85622 Feldkirchen Germany

Bio-Rad Laboratories Ges.m.b.H Am Europlatz 2 1120 Wien Austria

Bio-Rad Laboratories AG Pra Rond 23 1785 Cressier FR Switzerland

Bio-Rad Laboratories S.r.l. Via Cellini 18/A Segrate (Milan), Italy

Bio-Rad Laboratories S.A. Ed. "M" Miniparc II, C/Calendula 95, Alcobendas (Madrid) Spain

Bio-Rad Laboratories Lda Torre Monsanto Rua Afonso Praca 30, Algés (Lisbon), Portugal

Bio-Rad Laboratories M.EPE, Athens Tower 2-4 Mesogion Ave. Ampelokipi, Athens Greece

 

Facility Type

Sales & Service Organization

QMS Scope

Sales, technical support and after-sales service of life science research products and in vitro diagnostic medical devices.

ISO 14001:2015

Germany

June 17, 2024

Site Address

Bio-Rad Laboratories GmbH,
Kapellenstrasse 12, 85622 Feldkirchen,
Germany

Facility Type

Sales & Service Organization

EMS Scope

Sales, technical support and after-sales service of life science research products and in vitro diagnostic medical devices.

ISO 14001:2015

Nordics

November 29, 2025

Site Address

Bio-Rad Laboratories AB, Vretenvägen 13 B, 171 54, SOLNA, Sweden

Bio-Rad Laboratories AS, Torgbygget, Nydalsvelen 28, Oslo, NO-0484, Norway

Bio-Rad Finland OY Kutomotie 16, FI-00380 HELSINKI, Finland

Bio-Rad Denmark Aps, Symbion Science Park, Fruebjergvej 3, Kobenhavn O, DK-2100, Denmark

 

Facility Type

Sales & Service Organization

EMS Scope

Sales and after-sales service of life science research products and medical diagnostic product.