Elecsys Anti-HCV II (cobas e411/601/602) - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
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:
48366 - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
Therapeutic indications:
An electrochemiluminescence immunoassay "ECLIA" intended for use on the cobas e immunoassay analyzers for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV). The anti-HCV II is an in vitro diagnostic assay for the qualitative detection of antibodies to hepatitis C virus in serum and plasma. This electrochemiluminescence (ECLIA) assay is intended for use on Elecsys and cobas immunoassay analysers
Authorization status:
A
Authorization date:
2013-09-13
