PHASE Scientific Announces Indian CDSCO Approval for the PHASIFY™ VIRAL RNA Extraction Kit
Press ReleaseJuly 27, 2020
PHASE Scientific, a fast-growing biotechnology company, announces today it has received approval from India’s Central Drugs Standard Control Organization (CDSCO) for its PHASIFY™ VIRAL RNA Extraction Kit. This approval confirms that PHASIFY™ VIRAL complies with the provisions of India’s Medical Devices Rules, 2017, which enables PHASE Scientific to expand commercialization of PHASIFY™ VIRAL to India as part of the fight against COVID-19.
The CE-marked PHASIFY™ VIRAL RNA Extraction Kit is designed to purify and concentrate viral RNA in patient viral transport media samples, and is intended to help detecting and controlling the COVID-19 disease in India, which is currently the country with the 3rd-most COVID-19 infections. PHASIFY™ VIRAL improves input sample quality, enabling earlier detection, improved overall sensitivity and bolsters confidence in COVID-19 diagnostic test results.
PHASE Scientific has developed an array of products to combat COVID-19, which includes antibody rapid tests, sample preparation kits, and RT-qPCR kits. PHASE Scientific is currently providing their products globally to over 20 countries and regions.