Co-Diagnostics Joint Venture CoSara Receives CDSCO License to Manufacture PCR Pro Instrument in India

Reuters
Feb 05
Co-Diagnostics Joint Venture CoSara Receives CDSCO License to Manufacture PCR Pro Instrument in India

Co-Diagnostics Inc. announced that its joint venture, CoSara Diagnostics Pvt. Ltd. (CoSara), has received a license from the Central Drugs Standard Control Organization (CDSCO) to manufacture the CoSara PCR Pro™ real-time PCR point-of-care instrument at its facility in Ranoli, India. The CDSCO license, issued on Form MD-5, authorizes the manufacturing and sale or distribution of the CoSara-branded Class A medical device instrument. This represents the final instrument license required by CDSCO before commercialization can begin. CoSara PCR test kits to be used with the instrument, such as those for Mycobacterium tuberculosis $(MTB)$ and human papillomavirus (HPV), require separate regulatory clearance and are not yet available for sale.

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