Business
Co-Diagnostics JV, CoSara, Receives ISO 13485 Certification in Preparation for Manufacturing Upcoming PCR Platform
Co-Diagnostics, Inc. (OTC: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that CoSara Diagnostics Pvt. Ltd. ("CoSara"), the joint venture between Co-Dx and Ambalal Sarabhai Enterprises Limited (ASE Group), has successfully completed the necessary audits of its quality management system ("QMS") and that its manufacturing facility located in Vadodara, India, has been granted ISO 1
About this update from Ase Technology Holding Co., Ltd.
[{"type":"text","content":"Company and CoSara believe that ISO certification is a critical component of the regulatory requirements for clearance of new platform","length":134,"tagName":"p","attribs":{}},{"type":"text","content":"SALT LAKE CITY, Feb. 4, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (OTC: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that CoSara Diagnostics Pvt. Ltd. ("CoSara"), the joint venture between Co-Dx and Ambalal Sarabhai Enterprises Limited (ASE Group), has successfully completed the necessary audits of its quality management system ("QMS") and that its manufacturing facility located in Vadodara, India, has been granted ISO 13485:2016 certification.","length":624,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Co-Diagnostics)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Co-Diagnostics)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":184,"url":"https://media.zenfs.com/en/prnewswire.com/7a89e790bf1cbdd13a473c00e9766ccb"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/_YQ2JYyHRV7RlBcYGBsF.Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTMyNDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/7a89e790bf1cbdd13a473c00e9766ccb","width":400,"height":184}},"href":"https://mma.prnewswire.com/media/1856437/Co_Diagnostics_New_Logo_v1.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Mohal Sarabhai, CEO of CoSara, remarked, "Receiving this certification is a major milestone for CoSara, and validates the diligent work of our Quality team in building, streamlining, and maintaining our QMS to the highest international standards. We believe this certification will be a critical component to demonstrate to regulatory bodies in India and abroad that we meet the requirements for regulatory clearance of the upcoming PCR platform*, as well as for other medical device products across our full suite of offerings."","length":539,"tagName":"p"},{"type":"text","content":"The audits included a review of CoSara's QMS to ensure compliance with ISO 13485:2016, the international standard in quality management for organizations involved in the design, development and manufacture of medical devices. ISO 13485 certif...