2019-nCoV - India CDSCO Medical Device Registration
2019-nCoV is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000305_d6bf561a5aab73accbdee6b72dcc97c5_bb531e380420094848c40d4c9ad7b56d. This device is marketed under the brand name Corona Virus RT PCR Kit. The license holder is ADT India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Corona Virus RT PCR Kit
License Holder
ADT India Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The LyteStarTM 2019-nCoV RT-PCR Kit 1.0 is based on WHO recommendations for a broader screening test and a highly specific confirmation test and is designed as a dual target kit with a screening assay for SARS-related Coronaviruses based on the E gene and a highly specific confirmatory assay only for 2019-nCoV (Corona Virus RT PCR Kit), based on the RdRP-gene. The kit includes an Internal Control to identify possible PCR inhibition
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2019-nCoV
Brand: Corona Virus RT PCR Kit
2019-nCoV
Brand: Corona Virus RT PCR Kit