SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0691-070-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Xpert HIV-1 Viral Load XC
Assay Type
NAT - qPCR
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
Plasma
Product Code
Identification name
GXHIV-VL-XC-CE-10
Test kit package size
10