Roche Molecular Systems cobas 4800 HPV Test

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

Roche Diagnostics Asia Pacific Pte Ltd

Class:

Class C IVD

Manufactured by:

Roche Molecular Systems, Inc

Therapeutic area:

Microbiology

Therapeutic indications:

The cobas® 4800 Human Papillomavirus (HPV) Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies HPV16 and HPV18 while concurrently detecting the other high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) at clinically relevant infection levels. Specimens are limited to cervical cells collected in Roche Cell Collection Medium (Roche Molecular Systems, Inc.), PreservCyt® Solution (Hologic Corp.) and SurePathTM Preservative Fluid (BD Diagnostics- TriPath). The cobas® 4800 HPV Test can also be used with healthcare worker–instructed self- collected vaginal specimens collected in Roche Cell Collection Medium or PreservCyt® Solution.

Product summary:

Models: cobas® 4800 HPV Amplification/Detection Kit (960 Tests) - 05235910190, cobas® 4800 HPV Amplification/Detection Kit (240 Tests) - 05235901190, cobas® 4800 HPV Controls Kit 10 Sets - 05235855190, cobas z 480 complete - 05200881001, cobas® 4800 System Application Software (Core) Version 2.2.0.1509 - 07565500001, cobas® HPV AP v2.1.0.1570 - 07727984001

Authorization date:

2011-07-22