Procleix Ultrio Elite assay - HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Fáanlegur frá:

Grifols Australia Pty Ltd

Tegund:

Class 4

Framleitt af:

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

Lækningarsvæði:

62052 - HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Ábendingar:

The Procleix Ultrio Elite assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and human immunodeficiency virus type 2 (HIV) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors, tested individually. It is also intended for use in testing plasma and serum to screen organ and tissue donors, including cadaveric (non-heartbeating) donors. The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and human; immunodeficiency virus type 2 (HIV) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors, including donors of whole blood, blood components, and source plasma, and from other living donors. It is also intended for use in testing plasma and serum to screen organ and tissue donors when specimens are obtained while the donor?s heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors. This assay is not intended for use on cord blood specimens. It is also intended for use in testing pools of human plasma composed of equal aliquots of not more than 16 individual specimens from donors of plasma fractionation which is further manufactured into plasma-derived products which include viral inactivation and removal procedures only. This assay is not intended for use as an aid in diagnosis.; Note: This assay is not intended for detection of HIV-1, HIV-2, HCV, and HBV in pooled plasma and serum specimens from cadaveric (non-heartbeating) donors.

Leyfisstaða:

A

Leyfisdagur:

2018-07-27