SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0455-180-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Abbott RealTime High Risk HPV
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HPV NAT
Regulatory Version Submitted To PQ
Directive 98/79/EC: Self-declared CE-mark, Annex III
Applicant organization
Abbott GmbH - DUP
Max-Planck-Ring 2
Weisbaden,
65205
Germany
Pathogen
HPV
Specimen Type
Swab (cervicovaginal)
Product Code
Identification name
02N09-080
Test Package Size
Abbott RealTime High Risk HPV Amplification Reagent Kit (02N09-092) 4 packs, 24 tests/pack
Abbott RealTime High Risk HPV Control Kit (02N09-080) 12 vials x 0
Abbott RealTime High Risk HPV Control Kit (02N09-080) 12 vials x 0
Identification name
02N09-092
Test Package Size
Abbott RealTime High Risk HPV Amplification Reagent Kit (02N09-092) 4 packs, 24 tests/pack
Abbott RealTime High Risk HPV Control Kit (02N09-080) 12 vials x 0
Abbott RealTime High Risk HPV Control Kit (02N09-080) 12 vials x 0
IVD Manufacturing Site(s)
Abbott GmbH - DUP
Max-Planck-Ring 2
Weisbaden,
65205
Germany