Grifols Procleix Zika Virus Assay

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:

Immunology

Therapeutic indications:

The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid test for the detection of Zika virus (ZIKV) RNA in plasma and serum specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors. It is also intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens. The assay is intended for use in testing individual donor samples. This assay is not intended for use as an aid in diagnosis of Zika virus infection.

Product summary:

Models: Procleix Zika Virus Assay Master Kit - PRD-04170, Procleix Zika Virus Assay Calibrators Kit - PRD-04171, Procleix Assay Fluids Kit - 303344, Procleix Auto Detect Reagents Kit - 303345, PROCLEIX PANTHER SYSTEM - 303160, Procleix Zika Virus Assay Master Kit - PRD-04228, Procleix Zika Virus Assay Calibrators Kit - PRD-04229, Procleix Reagent Preparation Incubator 250 - 740820, Procleix NAT Manager v1.2 Software - 740648, Procleix Panther System featuring ART - PRD-05409, 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, 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, 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, Remote Access Software Options (3); 1) TeamViewer QuickSupport Software - SW-05872, Remote Access Software Options (3): 2) Remote Desktop, AnyConnect Software - SW-05909, Remote Access Software Options (3): 3) Remote Desktop, AnyConnect Self-Service Software - SW-05910

Authorization date:

2018-02-14