Procleix Ultrio Plus Assay - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Disponible desde:

Grifols Australia Pty Ltd

clase:

Class 4

Fabricado por:

Grifols Diagnostic Solutions Inc 4560 Horton Street, Emeryville, CA, 94608 United States Of America

Área terapéutica:

48216 - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

indicaciones terapéuticas:

The Procleix 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 samples from human donors, tested individually. it is also intended for use in testing plasma and serum to screen orand and tissue donors, including cadaveric (non heart-beating) donors. It is not intended for use on samples of cord blood. The Procleix 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 samples from human donors, tested individually. it is also intended for use in testing plasma and serum to screen orand and tissue donors, including cadaveric (non heart-beating) donors. It is not intended for use on samples of cord blood. The assay is not intended for use as an aid in diagnosis

Estado de Autorización:

A

Fecha de autorización:

2018-07-27