Transcription of WHO Prequalification of In Vitro Diagnostics PUBLIC …
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WHO Prequalification of In Vitro Diagnostics PUBLIC …
PQDx 0260-070-00 WHO PQ PUBLIC Report April/2017, version WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: Xpert HCV Viral Load with GeneXpert Dx, GeneXpert Infinity-48s, and GeneXpert Infinity-80 WHO reference number: PQDx 0260-070-00 Xpert HCV Viral Load with GeneXpert Dx, GeneXpert Infinity-48s, and GeneXpert Infinity-80 manufactured by Cepheid AB, CE marked, was accepted for the WHO list of prequalified in Vitro Diagnostics and was listed on 04 April 2017. Intended use: Xpert HCV Viral Load, performed on GeneXpert Instrument Systems is designed for the quantitation of hepatitis C virus (HCV) RNA in human serum or plasma (EDTA) from HCV-infected individuals. The test utilizes automated reverse transcriptase polymerase chain reaction (RT-PCR) using fluorescence to detect the RNA of interest for the quantitation of HCV. Xpert HCV Viral Load quantifies HCV genotypes 1 6 over the range of 10 to 100,000,000 IU/mL.
Xpert® HCV Viral Load 1 301-3019, Rev. D August 2016 Xpert® HCV Viral Load For In Vitro Diagnostic Use Only. 1 Proprietary Name Xpert® HCV Viral Load 2 Common or Usual Name HCV VL 3 Intended Use The HCV VL Assay, performed on GeneXpert® Instrument Systems, is designed for the rapid quantitation of Hepatitis C Virus (HCV) …
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