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CDSCO UID IMP/IVD/2020/000305_d6bf561a5aab73accbdee6b72dcc97c5_dd0158af8e24326835a8d9cf5a12f97b

2019-nCoV

ADT India Pvt. Ltd.·Device Class Class C·India CDSCO·Brand: Corona Virus RT PCR Kit
Registration details
UID
IMP/IVD/2020/000305_d6bf561a5aab73accbdee6b72dcc97c5_dd0158af8e24326835a8d9cf5a12f97b
Device class
Class C
Brand name
Corona Virus RT PCR Kit
License holder
ADT India Pvt. Ltd.
Approving authority
CDSCO
Product information
The LyteStar™ 2019-nCoV RT-PCR Kit 2.0 is intended for the specific detection of SARS-CoV-2 RNA in human respiratory specimens (Corona Virus RT PCR Kit). The LyteStar™ 2019-nCoV RT-PCR Kit 2.0 is a dual target assay comprising a screening assay targeting the E gene and a confirmation assay targeting the RdRP gene.
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About this record

2019-nCoV is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000305_d6bf561a5aab73accbdee6b72dcc97c5_dd0158af8e24326835a8d9cf5a12f97b. 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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