SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0268-070-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Xpert HPV
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HPV 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
HPV
Specimen Type
Whole blood (venous)
Product Code
Identification name
GXHPV-CE-10
Test kit package size
10