Roche Molecular Systems cobas 580068008800 HPV Test

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Disponibil de la:

Roche Diagnostics Asia Pacific Pte Ltd

Clasă:

Class C IVD

Produs de:

Roche Molecular Systems, Inc

Zonă Terapeutică:

Microbiology

Indicații terapeutice:

cobas® HPV for use on the cobas® 5800/6800/8800 Systems (cobas® HPV) is an automated qualitative in vitro test for the detection of human papillomavirus (HPV) DNA 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 SurePath™ Preservative Fluid (BD Diagnostics-TriPath). cobas® HPV can also be used with healthcare worker–instructed self-collected vaginal specimens collected in Roche Cell Collection Medium or PreservCyt® Solution.

Rezumat produs:

Models: cobas® HPV - 07460155190, cobas® HPV Positive Control Kit - 07460171190, cobas® Buffer Negative Control Kit - 07002238190, cobas® HPV - 09040544190, cobas® HPV Positive Control Kit - 09040552190, cobas® Buffer Negative Control Kit - 09051953190

Data de autorizare:

2019-09-10