SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
12411-045-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
BD Onclarity HPV Assay for the BD COR System
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;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)
Other
Product Code
Identification name
443982
Test kit package size
576
Test Package Size
refer to IFU