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

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Grifols Australia Pty Ltd

Klasse:

Class 4

Fremstillet af:

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

Terapeutisk område:

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

Terapeutiske indikationer:

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

Autorisation status:

A

Autorisation dato:

2018-07-27