PerkinElmer receives commercial approval from the Central Drugs Standard Control Organization, India for its SARS-CoV-2 real-time RT-PCR Assay
Jun 10, 2020
New Delhi [India] June 10 (ANI/BusinessWire India): PerkinElmer, Inc, a global leader committed to innovating for a healthier world, today announced that PerkinElmer India has received commercial approval by the Central Drugs Standard Control Organization (CDSCO) for the PerkinElmer new coronavirus nucleic acid detection kit.
This test is intended to help meet the heightened needs for COVID-19 testing in India.
PerkinElmer's RT-PCR test received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). It is also marketed as an in vitro diagnostic (IVD) device by meeting the requirements of the European In Vitro Diagnostic Directive (IVDD) and is now available in over 30 countries worldwide.
"COVID-19 continues to have a significant impact in India and it is imperative that testing facilities have the kits on hand to identify cases without delay. Receiving CDSCO approval for our RT-PCR test will bolster the solutions available to testing facilities across India and help toward improving health outcomes," said Shripad Joshi, Director, India and South Asia, PerkinElmer.
"Early detection is crucial to help control the spread of COVID-19 in the world's second-largest population, and the commercial approval for this new kit strengthens India's testing capabilities in order to more effectively address this pandemic," said Serge Moubarak, Managing Director, India, South Asia & Emerging Markets, PerkinElmer.
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