GDSBio has established a quality management system and obtained ISO 9001 and ISO 13485 certifications. The system contains QC documents to control the quality inspection process of products. The basic process is as follows:
Every product has passed strict quality inspection.
ISO 13485: 2016
ISO 9001: 2015
FDA registration
Business license
AUDITED SUPPLIER
CE certificate - sampling tube
CE certificate - viral nucleic acid extraction kit
CE certificate - COVID-19 nucleic acid detection kit
CFDA record - production
CFDA record - viral nucleic acid extraction kit
CFDA record - sampling tube