CoviDxTM mPlex-4R SARS-CoV-2 RT-PCR Detection Kit - India CDSCO Medical Device Registration
CoviDxTM mPlex-4R 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/2020/000150_a072ea51eb74555f2bc6b0791a3512f5_ccc1e2d12f6ba3e769c5e777269f2f86. 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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License Holder
NeoDx Biotech Labs Pvt LtdDevice Class
Approving Authority
Sub Zonal Bangalore
Product Information
The kit is intended for use for in-vitro RT-PCR qualitative assay for the specific detection of SARS-CoV-2 in human respiratory and serum specimens. This SARS-CoV-2 Primer and probe sets are designed for the detection of E-gene, N-gene and RdRP-gene along with internal control RNase P in a single tube assay, based on Berlin protocol., in-vitro testing only
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