PreciControl HIV Gen II - HIV1/HIV2 antigen/antibody IVD, control

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

现在购买

公众评估报告 公众评估报告 (PAR)
28-05-2019

可用日期:

Roche Diagnostics Australia Pty Limited

类:

Class 4

厂商:

Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany

治疗领域:

48449 - HIV1/HIV2 antigen/antibody IVD, control

疗效迹象:

PreciControl HIV Gen II is a lyophilized control serum based on human serum. The control levels 1, 2 and 3 are used for monitoring the accuracy of the Elecsys HIV combi PT and Elecsys HIV Duo assays. The control levels 1 and 3 are used for monitoring the accuracy of the Elecsys HIV Ag assay. PreciControl HIV Gen II is used for quality control of the Elecsys HIV combi PT, Elecsys HIV Duo and Elecsys HIV Ag immunoassays on the Elecsys and cobas e immunoassay analysers

授权状态:

A

授权日期:

2018-05-18

搜索与此产品相关的警报