PreciControl HIV; HIV-2+GrpO - HIV1/HIV2 antigen/antibody IVD, control
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
28-05-2019
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Available from:
Roche Diagnostics Australia Pty Limited
Class:
Class 4
Manufactured by:
Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany
Therapeutic area:
48449 - HIV1/HIV2 antigen/antibody IVD, control
Therapeutic indications:
PreciControl HIV; HIV-2+GrpO is a lyophilized control serum based on human serum. The controls are used for monitoring the accuracy of the Elecsys HIV combi PT and Elecsys HIV Duo assays. PreciControl HIV; HIV-2GrpO is used for quality control of the Elecsys HIV combi PT and Elecsys HIV Duo immunoassays on the Elecsys and cobas e immunoassay analysers
Authorization status:
A
Authorization date:
2018-05-18
