PreciControl Anti-HCV (cobas e 411/601/602) - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
22-11-2017
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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:
41973 - Hepatitis C virus total antibody IVD, control
Therapeutic indications:
PreciControl Anti-HCV is a ready-for-use control serum based on human serum both in the negative and positive concentration range. The controls are used for monitoring the accuracy of the Elecsys Anti-HCV and Elecsys Anti-HCV II immunoassays. PreciControl Anti-HCV is used for quality control of the Anti-HCV and Anti-HCV II immunoassays on the Elecsys and cobas e immunoassay analyzers.
Authorization status:
A
Authorization date:
2013-09-13
