Certificates of Analysis (CofA), Certificates of Conformance (CofC), and Master Lot Sheets

A Certificate of Analysis ascertains that a product has met its predetermined product release specification(s) and quality. Certificates of Analysis are available for In Vitro Diagnostic (IVD) kits and Translational Genomic (TG) products for customers on TG supply agreements. Certificates of Analysis can be used to satisfy qualification and/or acceptance activities. A Certificate of Conformance (also known as a Certificate of Compliance or a Certificate of Conformity) is a document certified by a competent authority that the supplied goods or service meets the required specifications.

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Where to look for a specific document

  • Certificate of Conformance Non-Dx - Visit the Product Lot Tracker
  • Certificate of Conformance Dx - Search by Serial number on this page
  • Certificate of Analysis - Search by Lot Number on this page
  • Master Lot Sheet - Search by Lot Number on this page

Need help finding a Lot Number or Serial Number? View label guide here