SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0634-078-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Aptima HPV 16 18/45 Genotype Assay
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
Hologic, Inc.
10210 Genetic Center Drive
San Diego,
92121
United States of America
Pathogen
HPV
Specimen Type
Swab (cervicovaginal)
Product Code
Identification name
303235
Test Package Size
p code 303236 - come sin 2 boxes - 1 at room temperature, 1 refrigerator storage
HPV 16 18/45 Amplification Reagent 1 vial
HPV 16 18/45 Enzyme Reagent 1 vial
HPV 16 18/45 Probe Reagent 1 vial
HPV 16 18/45 Internal Control Reagent 1 vial
HPV 16 18/45 Amplification reconstitution solution 1 vial
HPV 16 18/45 Enzyme reconstitution solution 1 vial
HPV 16 18/45 Probe reconstitution solution 1 vial
HPV 16 18/45 Selection Reagent 1 vial
HPV 16 18/45 Target capture Reagent 1 vial
Reconstitution collars x3 units
Master lot barcode sheet 1x sheet
Aptmia HPV 16 18/45 Genotype Assay Calibrators box - p
HPV 16 18/45 Amplification Reagent 1 vial
HPV 16 18/45 Enzyme Reagent 1 vial
HPV 16 18/45 Probe Reagent 1 vial
HPV 16 18/45 Internal Control Reagent 1 vial
HPV 16 18/45 Amplification reconstitution solution 1 vial
HPV 16 18/45 Enzyme reconstitution solution 1 vial
HPV 16 18/45 Probe reconstitution solution 1 vial
HPV 16 18/45 Selection Reagent 1 vial
HPV 16 18/45 Target capture Reagent 1 vial
Reconstitution collars x3 units
Master lot barcode sheet 1x sheet
Aptmia HPV 16 18/45 Genotype Assay Calibrators box - p
Identification name
303236
Test Package Size
p code 303236 - come sin 2 boxes - 1 at room temperature, 1 refrigerator storage
HPV 16 18/45 Amplification Reagent 1 vial
HPV 16 18/45 Enzyme Reagent 1 vial
HPV 16 18/45 Probe Reagent 1 vial
HPV 16 18/45 Internal Control Reagent 1 vial
HPV 16 18/45 Amplification reconstitution solution 1 vial
HPV 16 18/45 Enzyme reconstitution solution 1 vial
HPV 16 18/45 Probe reconstitution solution 1 vial
HPV 16 18/45 Selection Reagent 1 vial
HPV 16 18/45 Target capture Reagent 1 vial
Reconstitution collars x3 units
Master lot barcode sheet 1x sheet
Aptmia HPV 16 18/45 Genotype Assay Calibrators box - p
HPV 16 18/45 Amplification Reagent 1 vial
HPV 16 18/45 Enzyme Reagent 1 vial
HPV 16 18/45 Probe Reagent 1 vial
HPV 16 18/45 Internal Control Reagent 1 vial
HPV 16 18/45 Amplification reconstitution solution 1 vial
HPV 16 18/45 Enzyme reconstitution solution 1 vial
HPV 16 18/45 Probe reconstitution solution 1 vial
HPV 16 18/45 Selection Reagent 1 vial
HPV 16 18/45 Target capture Reagent 1 vial
Reconstitution collars x3 units
Master lot barcode sheet 1x sheet
Aptmia HPV 16 18/45 Genotype Assay Calibrators box - p