CoSara Diagnostics, a joint venture company of Co-Diagnostics Inc, USA and a Synbiotics, a wholly owned subsidiary of Ambalal Sarabhai Enterprises, has obtained regulatory clearance for five tests to be manufactured and sold as in vitro diagnostics (IVDs) from their facility in Ranoli India.
The test for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus (HPV) meet the requirements of the Central Drug Standard Control Organization (CDSCO) Medical Device Rules (MDR), 2017.
Regulatory clearance allows CoSara for the first time to manufacture and sell the test for the detection of the respective pathogens and microorganisms.
Ambalal Sarabhai Enterprises is engaged in manufacturing and marketing of pharmaceutical products, bulk drugs, industrial chemicals, detergents, toiletries, electronics, engineering products, paper, glass and plastic containers and packaging materials.
