JAK2 V617F Mutation RT-PCR Detection Kit - India CDSCO Medical Device Registration
JAK2 V617F Mutation RT-PCR Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000166_9a3b013c87371640d4d3dbbbf7c0e674_f866e862d7b0d5afbccfc249640bb154. This device is marketed under the brand name NeoDx. 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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Brand Name
NeoDx
License Holder
NeoDx Biotech Labs Pvt LtdDevice Class
Approving Authority
Sub Zonal Bangalore
Product Information
JAK2 V617F Mutation Detection Kit is a Real time PCR in vitro diagnostic kit for the detection of JAK2 (NeoDx) V617F allele in genomic DNA extracted from EDTA whole blood against a background of wild type genomic DNA. The mutation observed is a Guanine to Thymine transversion in position 1849 of the JAK2 gene, which leads to a valine to phenylalanine substitution in position 617 of the protein
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