The BioLegend Inc. Quality Management System (QMS) is certified through our accredited Notified Body TÜV SÜD to ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP).
All products sold by BioLegend Inc. comply with the requirements of ISO 13485:2016. This includes products labelled as Research Use Only (RUO) or GMP Research Use Only (GMP RUO), Analyte Specific Reagents (ASRs), and In Vitro Diagnostics (IVDs) including CE-Marked and registered products in selected countries. Compliance to ISO 13485:2016 ensures all products developed, manufactured and distributed by BioLegend Inc. meet defined requirements for the following QMS processes:
The MDSAP certification applies to BioLegend’s IVD, ASR, and GMP RUO products produced in our dedicated GMP Suites. To earn MDSAP certification, a company must comply with ISO 13485:2016 and meet country-specific regulatory requirements. BioLegend is currently certified as compliant to the country-specific MDSAP requirements for the United States and Canada.
A Certificate of Analysis (CoA) contains lot-specific information for a product. To generate the CoA for a product purchased from BioLegend, use our webtool. It only requires your lot number (which begins with B and contains 6 digits).
*Please note that CoAs for kits are not available online. Please contact our technical services group to obtain it.