SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0453-070-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Xpert HCV VL Fingerstick
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HCV NAT
Regulatory Version Submitted To PQ
Directive 98/79/EC: Product design examination certificate, Annex IV.4
Applicant organization
Cepheid AB
Röntgenvägen 5
Solna,
17127
Sweden
Pathogen
HCV
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
GXHCV-FS-CE-10
Test kit package size
10
Test Package Size
Assay Cartridges
1 CD with assay definition file, instructions to import ADF into GeneXpert software, IFU
1 CD with assay definition file, instructions to import ADF into GeneXpert software, IFU
IVD Manufacturing Site(s)
Cepheid AB
Röntgenvägen 5
Solna,
17127
Sweden
Cepheid AB
16311 220th Street SE Canyon Park Bldg. A
Bothell,
Washington
9820
United States of America