Grifols Procleix Ultrio Elite Assay System

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Dostopno od:

GRIFOLS ASIA PACIFIC PTE. LTD.

Razred:

Class D IVD

Izdeluje:

Grifols Diagnostic Solutions Inc.

Terapevtsko območje:

Immunology

Terapevtske indikacije:

The PROCLEIX Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and human immunodeficiency virus type 2 (HIV) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors, tested individually or in pools. It is also intended for use in testing plasma and serum to screen organ and tissue donors, including cadaveric (non-heart-beating) donors. It is not intended for use on samples of cord blood. This assay is not intended for use as an aid in diagnosis.

Povzetek izdelek:

Models: Procleix Ultrio Elite Assay Kit - 303330, Procleix Ultrio Elite Target Enhancer Reagent Kit - 303331, Procleix Ultrio elite HIV, HCV and HBV Discriminatory Probe Reagents Kit - 303334, Procleix Ultrio Elite Negative Calibrators Kit - 303333, Procleix Ultrio Elite Positive Calibrators Kit - 303332, Procleix Assay Fluid Kit - 303344, Procleix Autodetect Kit - 303345, Procleix Panther System - 303160, Reagent Preparation Incubator 250 - 740820, Procleix NAT Manager Software v.1.2 - 740648, SW, PANTHER SYSTEM IVD V7.1 - SFW-02123, SW PANTHER SHIELD V2.0.27 - SFW-02096, PANTHER IMAGE (Dell Optiplex XE2) - SFW-02021, Procleix Ultrio Elite Assay Kit (5000 Test Kit) - 303715, Procleix Ultrio Elite Target Enhancer Reagent Kit (5000 Test Kit ) - 303722, Procleix Ultrio Elite Assay Calibrators Kit (low volume) - 303719, Procleix Ultrio Elite Assay Calibrators Kit (high volume) - 303723, Procleix Panther System featuring ART - PRD-05409, On-demand Access Waste Module; on demand Access Universal Fluids Module - ASY-13103, MTU Expansion Module - ASY-13105, Waste-to-Drain Module - ASY-13106, Sample Shuttle Module - ASY-13472, Panther 6.0.13 Image (Windows 10) - SW-06109, Panther Shield Software - SW-05178, Panther Instrument Setup (Firmware) - SW-05963, Panther System Software - SW-05962, Remote Access Software Options (3); 1) TeamViewer QuickSupport Software, 2) Remote Desktop, AnyConnect Software, 3) Remote Desktop, AnyConnect Self-Service Software - SW-05872, SW-05909 or SW-05910, Procleix Assay Software V1.0 - SW-05625, Panther System Help File - SW-05844, Panther Dashboard Data Storage - SW-05929, Procleix Dashboard Help (CE-IVD) - SW-05926, Panther XE2 PC with 6.0.13 Image - CMP-01605, Panther Workstation Computer, DELL Optiplex XE3 - CMP-01672

Datum dovoljenje:

2013-06-12