SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
12315-045-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
BD Onclarity HPV Assay for the BD Viper LT System
Assay Type
NAT (nucleic acid testing)
NAT - PCR
IVD Public Report Category
HPV NAT
Regulatory Version Submitted To PQ
Directive 98/79/EC: Self-declared CE-mark, Annex III;JMHLW: Other;TGA: ARTG Number
Applicant organization
Becton, Dickinson and Company, BD Biosciences - MD Site
7 Loveton Circle
Sparks,
Maryland
21152-0999
United States of America
Pathogen
HPV
Specimen Type
Swab (cervicovaginal)
Product Code
Identification name
442946
Test kit package size
192
Test Package Size
2x96
BD ViperTM LT Pipette Tips 440330 3,840 tips
BD ViperTM Waste Liners 442968 100 liners
BD ViperTM LT PCR Accessory Kit 442967 80 pieces
BD Pierceable Caps 440295 200 caps
BD Pierceable Caps Pink 440331 400 caps
BD ViperTM LT PCR Tube/Tray Kit 442957 20 pieces
BD Key Card 443747 1,000 each
BD ViperTM XTR Neutralization Pouch 441354 12 pouches
BD ViperTM LT Pipette Tips 440330 3,840 tips
BD ViperTM Waste Liners 442968 100 liners
BD ViperTM LT PCR Accessory Kit 442967 80 pieces
BD Pierceable Caps 440295 200 caps
BD Pierceable Caps Pink 440331 400 caps
BD ViperTM LT PCR Tube/Tray Kit 442957 20 pieces
BD Key Card 443747 1,000 each
BD ViperTM XTR Neutralization Pouch 441354 12 pouches