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CoviDx DirectPlex SARS-CoV-2 RT-PCR Detection Kit - India CDSCO Medical Device Registration

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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class C
CoviDx DirectPlex SARS-CoV-2 RT-PCR Detection Kit
UID: MFG/IVD/2021/000088_be28112cd0f95183f1e14a63071a7a00_10a46afb2302df3907474eefb60a694d

Brand Name

Nil

Device Class

Class C

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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