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ISO 13485 Certificates

 

At Agilent Technologies, we believe that our customers define quality. They do this every day with the products and services they purchase. Customers buy based on perceived value - that is, they measure the benefits against the costs and select the product and experience that provides superior value. We, therefore, define Quality as customer perceived value.  Read Agilent's Quality Policy, Business Management System Manual, or a letter describing Agilent's ISO9001 registration status.
 
ISO 13485:2003 - Certain Life Sciences and Chemical Analysis entities are certified to this medical device standard
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clear bullet Agilent Technologies Genomics Division, Santa Clara, California - Scope: Manufacture of Microarrays and Microarray Accessories for in Vitro Diagnostic and General Laboratory Applications.
English ISO 13485 PDF (327KB)  
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clear bullet Agilent Technologies La Jolla, California and Cedar Creek, Texas - Scope: Design of Quantitative Polymerase Chain Reaction (QPCR) instruments, technical services and software design. Manufacture of bioreagents for In Vitro Diagnostic applications.
English ISO 13485 PDF (645KB)  
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clear bullet Agilent Technologies Manufacturing, Waldbronn Germany - Scope: Manufacture and distribution of bio-analytical instruments and related software for In Vitro Diagnostic applications.
English ISO 13485 PDF (92KB)  
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clear bullet Agilent Technologies Manufacturing, Little Falls, Delaware - Scope: Manufacture and distribution of instruments such as microarray scanners and mass spectrometer detectors, including GCMS, for In Vitro Diagnostic applications.
English ISO 13485 PDF (385KB)  
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clear bullet Agilent Technologies, Inc. Lake Forest Consumables Division, Lake Forest, CA - Scope: The design, development, manufacture, sale and distribution of laboratory chromatography supplies and point of care drugs of abuse test devices for in vitro diagnostic and forensic use.
English ISO13485  PDF  (379KB)
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clear bullet Agilent Technologies, Singapore Pte. Ltd. Inc. - Scope: Manufacture and distribution of analytical instrumentation systems and microarray scanner systems including related software.
English ISO13485  PDF  (400KB)
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