SARS-CoV-2 RT-PCR Kit 1.0 - India CDSCO Medical Device Registration
SARS-CoV-2 RT-PCR Kit 1.0 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000609_ca7c11ff696610bd76404b8cec2dc64d_97339853a9979007e01171b796d80f8a. This device is marketed under the brand name RealStar®. The license holder is M/s Avantor Performance Materials India Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
RealStar®
License Holder
M/s Avantor Performance Materials India LtdDevice Class
Approving Authority
CDSCO
Product Information
RealStar® SARS-CoV-2 RT-PCR Kit 1.0 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of lineage B-beta coronavirus (RealStar®) and severe acute respiratory syndrome coronavirus 2 (RealStar®) specific RNA.
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