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CDSCO UID MFG/IVD/2021/000088_be28112cd0f95183f1e14a63071a7a00_10a46afb2302df3907474eefb60a694d

CoviDx DirectPlex SARS-CoV-2 RT-PCR Detection Kit

NeoDx Biotech Labs Pvt Ltd·Device Class Class C·India CDSCO·Brand: Nil
Registration details
UID
MFG/IVD/2021/000088_be28112cd0f95183f1e14a63071a7a00_10a46afb2302df3907474eefb60a694d
Device class
Class C
Brand name
Nil
License holder
NeoDx Biotech Labs Pvt Ltd
Approving authority
Sub Zonal Bangalore
Product information
CoviDxTM DirectPlex SARS-CoV-2 RT-PCR Detection Kit is an in-vitro RNA extraction free, RT-PCR based qualitative assay for the specific detection of SARS-CoV-2 in human respiratory specimens. This kit uses one-step RT-qPCR with a hydrolysis probe chemistry that uses 5’ nuclease activity of Taq DNA polymerase and enables detection of PCR product which gets amplified at every step during PCR cycles by producing fluorescence.
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About this record

CoviDx DirectPlex SARS-CoV-2 RT-PCR Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000088_be28112cd0f95183f1e14a63071a7a00_10a46afb2302df3907474eefb60a694d. This device is marketed under the brand name Nil. The license holder is NeoDx Biotech Labs Pvt Ltd, and it is classified as Device Class Class C. The approving authority is Sub Zonal Bangalore.

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