CDSCO UID MFG/IVD/2020/000150_e74865df3cb4c1c5ddf4e7117ad92fd7_5aaeded2e93862ebd300a921aa9d3427

TripleH RT PCR Kit HIV, HBV & HCV Qualitative Detection Kit

NeoDx Biotech Labs Pvt Ltd·Device Class Class D·India CDSCO

Registration details

UID: MFG/IVD/2020/000150_e74865df3cb4c1c5ddf4e7117ad92fd7_5aaeded2e93862ebd300a921aa9d3427
Device class: Class D
License holder: NeoDx Biotech Labs Pvt Ltd
Approving authority: Sub Zonal Bangalore
Product information: NeoDx TripleH is an in-vitro RT PCR qualitative detection kit for detecting Human Hepatitis Viruses B and C and Human Immunodeficiency Viruses ##PLACEHOLDER_0##. NeoDx TripleH qPCR Kits are unique multiplex qPCR assays that allow simultaneous real-time PCR detection of HBV, HCV and HIV ##PLACEHOLDER_0## in human blood, serum and plasma, which are the sample types. Individual primers and probes have been designed to permit multiple detections in a single reaction through separate fluorescent channels. TripleH qPCR Kit also includes a human endogenous control to confirm the extraction of a valid biological template.

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About this record

TripleH RT PCR Kit HIV, HBV & HCV Qualitative Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000150_e74865df3cb4c1c5ddf4e7117ad92fd7_5aaeded2e93862ebd300a921aa9d3427. The license holder is NeoDx Biotech Labs Pvt Ltd, and it is classified as Device Class Class D. The approving authority is Sub Zonal Bangalore.

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