SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0633-078-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Aptima HPV 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
302554
Test Package Size
for both product codes (volume of reagents changes per quantity test/kit)
Aptima HPV Assay Refrigerated box
HPV Amplification Reagent 1 vial
HPV Enzyme Reagent 1 vial
HPV Probe Reagent 1 vial
HPV Internal Control Reagent 1 vial
Aptima HPV Assay Room Temperature Box
HPV Amplification Reconstitution Solution 1 vial
HPV Enzyme reconstitution solution 1 vial
HPV Probe reconstitution solution 1 vial
HPV selection reagent 1 vial
HPV target capture reagent 1 vial
reconstitution collars 3 units
master lot barcode sheet 1 sheet
Aptima HPV Assay calibrators box - product code 302554 - 5 each positive and negative calibrators
Aptima HPV Assay Refrigerated box
HPV Amplification Reagent 1 vial
HPV Enzyme Reagent 1 vial
HPV Probe Reagent 1 vial
HPV Internal Control Reagent 1 vial
Aptima HPV Assay Room Temperature Box
HPV Amplification Reconstitution Solution 1 vial
HPV Enzyme reconstitution solution 1 vial
HPV Probe reconstitution solution 1 vial
HPV selection reagent 1 vial
HPV target capture reagent 1 vial
reconstitution collars 3 units
master lot barcode sheet 1 sheet
Aptima HPV Assay calibrators box - product code 302554 - 5 each positive and negative calibrators
Identification name
302929
Test kit package size
100
Test Package Size
for both product codes (volume of reagents changes per quantity test/kit)
Aptima HPV Assay Refrigerated box
HPV Amplification Reagent 1 vial
HPV Enzyme Reagent 1 vial
HPV Probe Reagent 1 vial
HPV Internal Control Reagent 1 vial
Aptima HPV Assay Room Temperature Box
HPV Amplification Reconstitution Solution 1 vial
HPV Enzyme reconstitution solution 1 vial
HPV Probe reconstitution solution 1 vial
HPV selection reagent 1 vial
HPV target capture reagent 1 vial
reconstitution collars 3 units
master lot barcode sheet 1 sheet
Aptima HPV Assay calibrators box - product code 302554 - 5 each positive and negative calibrators
Aptima HPV Assay Refrigerated box
HPV Amplification Reagent 1 vial
HPV Enzyme Reagent 1 vial
HPV Probe Reagent 1 vial
HPV Internal Control Reagent 1 vial
Aptima HPV Assay Room Temperature Box
HPV Amplification Reconstitution Solution 1 vial
HPV Enzyme reconstitution solution 1 vial
HPV Probe reconstitution solution 1 vial
HPV selection reagent 1 vial
HPV target capture reagent 1 vial
reconstitution collars 3 units
master lot barcode sheet 1 sheet
Aptima HPV Assay calibrators box - product code 302554 - 5 each positive and negative calibrators
Identification name
303093
Test kit package size
250
Test Package Size
for both product codes (volume of reagents changes per quantity test/kit)
Aptima HPV Assay Refrigerated box
HPV Amplification Reagent 1 vial
HPV Enzyme Reagent 1 vial
HPV Probe Reagent 1 vial
HPV Internal Control Reagent 1 vial
Aptima HPV Assay Room Temperature Box
HPV Amplification Reconstitution Solution 1 vial
HPV Enzyme reconstitution solution 1 vial
HPV Probe reconstitution solution 1 vial
HPV selection reagent 1 vial
HPV target capture reagent 1 vial
reconstitution collars 3 units
master lot barcode sheet 1 sheet
Aptima HPV Assay calibrators box - product code 302554 - 5 each positive and negative calibrators
Aptima HPV Assay Refrigerated box
HPV Amplification Reagent 1 vial
HPV Enzyme Reagent 1 vial
HPV Probe Reagent 1 vial
HPV Internal Control Reagent 1 vial
Aptima HPV Assay Room Temperature Box
HPV Amplification Reconstitution Solution 1 vial
HPV Enzyme reconstitution solution 1 vial
HPV Probe reconstitution solution 1 vial
HPV selection reagent 1 vial
HPV target capture reagent 1 vial
reconstitution collars 3 units
master lot barcode sheet 1 sheet
Aptima HPV Assay calibrators box - product code 302554 - 5 each positive and negative calibrators