Grifols Procleix HEV 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:

The Procleix HEV Assay is a qualitative in vitro nucleic acid amplification test for the detection of hepatitis E virus (HEV) RNA in plasma and serum specimens from human donors. 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.

Product summary:

Models: Procleix Panther System - 303160, Procleix Panther System (ART, Continuous Fluid and Waste) - PRD-05490, Procleix Reagent Preparation Incubator 250 (RPI 250) - 740820, Advanced Cleaning Solution - PRD-04550, Continuous Access Kit w/ Assembled Waste Drawer - ASY-13103, MTU Expansion Module - ASY-13105, Waste-to-Drain Module - ASY-13106, Assy TR – Shuttle Module - ASY-13472, Procleix HEV Assay (1000 TEST KIT) - PRD-02789, Procleix HEV Assay (5000 test kit) - PRD-03042, Procleix Auto Detect Reagents - 303345 (1000 Tests), Procleix Assay Fluids - 303344 (1000 Tests), Procleix NAT Manager v1.2 Software - 740648, Procleix HEV Assay Calibrators (1000 TEST KIT) - PRD-02790, Procleix HEV Assay Calibrators (5000 kit) - PRD-03043, Patch v4 for Procleix NAT Manager v1.2, Software upgrade, Build 1.2.2.19 - 741363

Authorization date:

2022-04-06