PerkinElmer Receives Commercial Approval From the Central Drugs Standard Control Organization, India for Its SARS-CoV-2 Real-Time RT-PCR Assay
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Date: 10-06-2020 10:50AM
Source: PerkinElmer (India) Pvt Ltd
Category: General, Consumer Interest, Science & Research, Healthcare & Biotechnology, Pharmaceutical
Location: New Delhi, Delhi, India
Business Wire India
 | | PerkinElmer® New Coronavirus Nucleic Acid Detection Kit |
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 U.S. 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. About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
About PerkinElmer in India
With a mission focused on innovating for a healthier world, PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges in science and health by offering unique instruments, informatics and service solutions for advanced testing and analysis. Since 1981, PerkinElmer has worked with customers in India, spanning a wide range of markets including pharmaceutical, food, life science, diagnostics, and applied markets. PerkinElmer established direct operations in India in 2004 and currently has more than 10,000 customers and over 550 employees in India and South Asia. Additional information is available at www.perkinelmer.com.
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