Jan. of 2012: the company established an integral quality management system.
Nov. of 2012: obtained "China Public Security Product Certificate";
Jun. of 2013: acquired "Medical Device Manufacturer License" issued by Zhejiang Province Food and Drug Administration;
Sep. of 2013: obtained "EN ISO 9001: 2008; EN ISO 13485: 2012 Quality Management System Certificate" issued by TUV Rheinland 

certification authority;
Jan. of 2014: four nucleic acid extraction kits of the company obtained the registration of class one reagent products;
Mar. of 2014: obtained "ISO 14001: 2004 Environmental Management System Certificate" issued by UKAS certification authority;
Aug. of 2014: successfully passed the “in vitro diagnostic reagents production quality management system assessment” inspected by 

the Zhejiang Food and Drug Administration;

Feb. of 2015: three products of the company, human papillomavirus (HPV) 25x genotyping kit, ALDH2 and ADH1B genotyping kit and 

CYP2C19 genotyping kit, were accepted by CFDA for registration.


Registration & Certification

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