Abbott RealTime CMV

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

متاح من:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

الفئة:

Class C IVD

المصنعة من قبل:

Abbott Molecular Inc

المجال العلاجي:

Microbiology

الخصائص العلاجية:

The Abbott RealTime CMV assay is an in vitro polymerase chain reaction (PCR) assay for the quantification of cytomegalovirus (CMV) DNA in human plasma or whole blood. The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of initiation of therapy and for use as an aid in monitoring viral response to antiviral treatment as measured by changes in plasma or whole blood DNA levels. This assay is not intended to be used as a screening for CMV or as a diagnostic test to confirm the presence of CMV infection.

ملخص المنتج:

Models: Abbott RealTime CMV Calibrator Kit - 05N23-70, Abbott RealTime CMV Calibrator A - 5N23A, Abbott RealTime CMV Calibrator B - 5N23B, Abbott RealTime CMV Control Kit - 05N23-80, Abbott RealTime CMV Negative Control - 5N23Z, Abbott RealTime CMV Positive Control - 5N23W, Abbott RealTime CMV Amplification Reagent Kit - 05N23-90, Abbott RealTime CMV Internal Control - 5N23Y, Abbott RealTime CMV Amplication Reagent Pack - 5N23, Abbott RealTime CMV m2000 System ROW Combined Application CD-ROM v2.0 or above - 05N23-XX, Abbott m2000sp - E Series - 09K14-02, Abbott m2000rt - 09K15-01, Abbott m24sp - 03N06-01, ABBOTT mSample Preparation System DNA Reagents - 06K12-24, Abbott m24sp Script Database Software v6.xx or above - 50-148360, Abbott m2000rt Software Release 6.0 - 50-148401, Abbott m2000sp Software Release 6.0 - 50-148400, Abbott m2000sp Software Release 8.0 - 50-148393, Abbott m2000rt Software Release 8.0 - 50-148392, Abbott m2000sp Software Release 8.1 - 50-148440, Abbott m2000rt Software Release 8.1 - 50-148441

تاريخ الترخيص:

2012-10-16