Abbott RealTime HIV-1 Qualitative

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

זמין מ:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

סיווג:

Class D IVD

תוצרת:

Abbott Molecular Inc

איזור תרפויטי:

Microbiology

סממני תרפויטית:

The Abbott RealTime HIV-1 Qualitative is an in vitro amplification assay for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acids from human plasma and dried blood spots (DBS). The Abbott RealTime HIV-1 Qualitative is intended to be used as an aid in the diagnosis of HIV-1 infection in pediatric and adult subjects. The Abbott RealTime HIV-1 Qualitative is not intended to be used as a donor screening test for HIV-1. The product has not been evaluated in pregnant or postpartum women.

leaflet_short:

Models: Abbott RealTime HIV-1 Negative Control - 2G31Z, Abbott RealTime HIV-1 High Positive Control - 2G31X, Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit - 04N66-90, Abbott RealTime HIV-1 Internal Control - 2G31Y, Abbott m2000sp - E Series - 09K14-02, Abbott m2000rt - 09K15-01, ABBOTT mSample Preparation System DNA Reagents - 06K12-24, Abbott RealTime HIV-1 Qualitative Control Kit - 04N66-80, Abbott RealTime HIV-1 Qualitative Amplication Reagent Pack - 4N66, Abbott RealTime HIV-1 Qualitative m2000 System Combined Application CD-ROM - 04N66.XX, 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

תאריך אישור:

2012-11-21