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Quality Management Systems Certificates

Quality Management Systems Certificates

At BD Biosciences, we ensure that we work within recognized quality accreditations and standards. We have established innovation- and process-based centers across the globe. Our manufacturing sites follow strict adherence to the highest standards of quality and compliance.

Below are links to certifications for our other manufacturing sites:

 

Notified Body

Manufacturing Site

Product Portfolio

Site Certification

BSI

Milpitas, CA, USA

In vitro diagnostic, clinical and research devices, reagents, instruments (including flow cytometers), and  software for cell sorting and enumeration of  tissue  and biological fluid samples such as blood and blood  components

ISO 9001:2015 FM783029

 

ISO 13485:2016 & EN ISO 13485:2016 MD783027

 

ISO 13485:2016 MDSAP 783030  

 

IVDR 728780

BSI

San Diego,  CA, USA

Antibodies and associated biological reagents for research use

ISO 9001:2015 FM502583

 

ISO 13485:2016 MD796285        

BSI

Cayey, Puerto Rico

Reagents for In-Vitro Cell Analysis

ISO 9001:2015 FM536002

 

ISO 13485:2016 FM545222

TUV

Tatabanya, Hungary

Antibodies associates biological reagents for research use

ISO 9001:2015 No. 01 100 1824102

BSI

Salamanca, Spain

Antibodies, reagents, kits and software for Flow Cytometry for In vitro Diagnostics

ISO 9001:2015 FM791444

 

ISO 13485:2016 & EN ISO 13485:2016 MD791433

BSI

Temse, Belgium

Storage, distribution and transportation of BD Healthcare products in compliance with internal and external service level agreements

ISO 13485:2016 MD611845