BD Onclarity™ HPV Assay

Singapore - English - HSA (Health Sciences Authority)

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Available from:
BECTON DICKINSON HOLDINGS PTE. LTD.
Class:
Class C IVD
Manufactured by:
Becton, Dickinson and Company (BD)
Therapeutic area:
Microbiology
Therapeutic indications:
The BD Onclarity™ HPV Assay is an amplified DNA test for the qualitative detection of high risk types of human papillomavirus (HPV). The assay detects all high risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and provides the capability for genotyping of six high risk types (HPV 16, 18, 31, 45, 51 and 52). Cervical specimens that are tested with the BD Onclarity HPV Assay include the BD Onclarity HPV Cervical Brush Collection Kit, BD SurePath™ Preservative Fluid, and PreservCyt® Solution (using an aliquot that is removed prior to or after processing for either the BD SurePath or ThinPrep™ Pap test). The BD Onclarity HPV Assay is performed with the BD Viper™ LT System.
Product summary:
Models: BD Onclarity™ HPV Assay - 442946, BD Viper™ PCR Extraction Reagent Trough with Piercing Tool - 442841, BD FOX™ PCR Extraction Tubes - 441992, Control set for the BD Onclarity™ HPV Assay - 441993, BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes - 442840, BD Viper™ LT System Instrument - 442839
Authorization number:
DE0503434
Authorization date:
2019-08-05

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