Dx Focus: PrimeraDx Gets Medical Device Manufacturing Certification

Jan 19, 2012

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PrimeraDx said this week that it has received certification for ISO 13485:2003, an International Organization for Standardization medical device quality management standard.

BSI Group America performed the review according to ISO 13485:2003 requirements, and focused on PrimeraDx’s design, manufacturing, and distribution of multiplex instrumentation and assays for molecular diagnostics.

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