SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0260-070-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Xpert HCV Viral Load with GeneXpert Dx, GeneXpert Infinity-48s, and GeneXpert Infinity-80
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
Plasma
Serum
Product Code
Identification name
GXHCV-VL-CE-10
Test kit package size
10
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