Abbott RealTime™ HIV-1

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Tilgjengelig fra:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Klasse:

Class C IVD

Produsert av:

Abbott Molecular Inc

Terapeutisk område:

Microbiology

Indikasjoner:

The Abbott RealTime HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of Human Immunodeficiency virus type 1 (HIV-1) in human plasma from HIV-1 infected individuals. The Abbott RealTime HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. This assay is not intended to be used as a screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.

Produkt oppsummering:

Models: Abbott Real Time HIV-1 Calibrator Kit - 2G31-70, Abbott Real Time HIV-1 Control Kit - 2G31-80, Abbott Real Time HIV-1 Amplification Reagent Kit - 2G31-90, Abbott m2000sp - G Series - 9K14-01, Abbott m2000sp - E Series - 9K14-02, Abbott m24sp - 3N06.01, Abbott m2000rt - 9K15-01, ABBOTT RealTime HIV-1 m2000 ROW System Combined Application CD-ROM - 1L68, ABBOTT RealTime HIV-1/HCV maxCycle m2000 ROW System Combined Application CD-ROM - 3N23, ABBOTT mSample Preparation System Reagents - 4J70-24, ABBOTT mSample Preparation System DNA Reagents - 6K12-24, Abbott m2000rt Software Release 6.0 - 50-148401, Abbott m2000sp Software Release 6.0 - 50-148400, ABBOTT RealTime HIV-1 m2000 ROW System Combined Application CD-ROM version 11 - 1L68-11, Uracil-N-Glycosylase (UNG) - 6L87-02, Abbott m2000sp Software Release 8.0 - 50-148393, Abbott m2000rt Software Release 8.0 - 50-148392, Abbott m24sp Script Database Software v6.xx or above - 50-148360, Abbott m2000sp Software Release 8.1 - 50-148440, Abbott m2000rt Software Release 8.1 - 50-148441

Autorisasjon dato:

2010-10-06