CDSCO UID MFG/IVD/2021/000113_0df16b91c948eef44af6fc49eb6e92b9_970a14ffa956fc8e231b2bcfa3651c6b

Rapid Immunochromatography Test For HCV (FLAVISCREEN HCV PLUS )-Flaviscreen HCV Plus is a rapid, third generation two-site sandwich immunoassay for the detection of total antibodies specific to Hepatitis C virus . The test employs a genotype cross-reactive multi-epitope recombinant antigen derived from the Core, NS3, NS4 and NS5 regions of multiple HCV genotypes. The double antigen sandwich system ensures detection of all anti-HCV antibody isotopes to all major HCV genotypes,: Rapid Immunochromatographic Test System Pack for Simultaneous Detection of HIV ½ antibodies, HCV antibodies, Syphilis antibodies and HBsAg In Human Serum/Plasma(VIRDICT 4 )

QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED·Device Class Class D·India CDSCO·Brand: Device
Registration details
UID
MFG/IVD/2021/000113_0df16b91c948eef44af6fc49eb6e92b9_970a14ffa956fc8e231b2bcfa3651c6b
Device class
Class D
Brand name
Device
Approving authority
Sub Zonal Goa
Product information
The Virdict 4 (Device) is a rapid, qualitative, immunochromatographic assay for the detection of HIV, Hepatitis C Virus, Syphilis antibodies and Hepatitis Surface Antigen (Device) in human serum/plasma
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About this record

Rapid Immunochromatography Test For HCV (FLAVISCREEN HCV PLUS )-Flaviscreen HCV Plus is a rapid, third generation two-site sandwich immunoassay for the detection of total antibodies specific to Hepatitis C virus . The test employs a genotype cross-reactive multi-epitope recombinant antigen derived from the Core, NS3, NS4 and NS5 regions of multiple HCV genotypes. The double antigen sandwich system ensures detection of all anti-HCV antibody isotopes to all major HCV genotypes,: Rapid Immunochromatographic Test System Pack for Simultaneous Detection of HIV ½ antibodies, HCV antibodies, Syphilis antibodies and HBsAg In Human Serum/Plasma(VIRDICT 4 ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000113_0df16b91c948eef44af6fc49eb6e92b9_970a14ffa956fc8e231b2bcfa3651c6b. This device is marketed under the brand name Device. The license holder is QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class D. The approving authority is Sub Zonal Goa.

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