SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0652-070-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Xpert HIV-1 Qual XC
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
Whole blood (capillary)
Whole blood (venous)
Whole blood (dried blood spot)
Product Code
Identification name
GXHIV-QA-XC-CE-10
Test kit package size
10
Test Package Size
GHIV-QA-XC-CE-10
10x Xpert HIV-1 Qual XC Cartridge with Integrated Reaction Tube
1x CD [containing: Assay Definition File (ADF), Instructions to import ADF into software and Instructions for Use]
1 bage of 10 per kit Disposable transfer pipettes
10x Xpert HIV-1 Qual XC Cartridge with Integrated Reaction Tube
1x CD [containing: Assay Definition File (ADF), Instructions to import ADF into software and Instructions for Use]
1 bage of 10 per kit Disposable transfer pipettes