Grifols Procleix Ultrio Plus Assay System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

GRIFOLS ASIA PACIFIC PTE. LTD.

Class:

Class D IVD

Manufactured by:

Grifols Diagnostic Solutions Inc.

Therapeutic area:

Microbiology

Therapeutic indications:

TheProcleix® Ultrio® Plus Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 (HIV-1) 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-heartbeating) donors. It is not intended for use on samples of cord blood.

Product summary:

Models: Procleix Ultrio Plus 5000Test kit - 302574, Procleix Ultrio Plus 1000 test kit - REF 302573, Procleix HCV Discriminatory Probe Reagent Kit - REF 302577, Procleix HIV-1 Discriminatory Probe Reagent Kit - REF 302571, Procleix HBV Discriminatory Probe Reagent Kit - REF 302576, Procleix Auto Detect Reagents Kit - REF 301120, Procleix Ultrio Plus TIGRIS Controls Kit - 302572, Procleix Tigris System - REF 105226, Reagent Preparation Incubator - REF 900722, Tecan Genesis RSP - 10611448, Procleix TCS - 104988, Procleix HC+ Luminometer - 104978E, Procleix System fluid Preservative - REF301175, Procleix Ultrio Plus Assay Negative Calibrators - 303260, Procleix Ultrio Plus TIGRIS Negative Controls - 303261, Procleix Wash Solution - REF 303665, Procleix Buffer for Deactivation Fluid - REF 303666, Procleix Oil - REF 302441, Procleix® Tigris® System Procleix® Assay Software - SFW-02247, Tigris® System Software - SFW-02245, Procleix Ultrio Plus Assay Calibrators Kit - 302575, Procleix Ultrio Plus HIV-1, HCV, HBV Discriminatory Probe Reagents Kit - PRD-03709

Authorization date:

2011-04-04