SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0193-070-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Xpert HIV-1 Quant with GeneXpert Instrument Systems (GeneXpert Infinity-48)
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HIV 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
HIV
Specimen Type
Serum
Product Code
Identification name
GXHIV-VL-CE-10
Test kit package size
10
Test Package Size
10 x Xpert HIV-1 Viral Load cartridges with integrated reaction tubes, Disposable 1 mL transfer pipettes (1 bag of 10 per kit) and 1 x CD (CD (includes instructions for use)
IVD Manufacturing Site(s)
Cepheid (Instruments)
904 Caribbean Drive
Sunnyvale,
94089
United States of America