Elecsys CMV IgG (cobas e 411/601/602) - Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
26-05-2019
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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:
49713 - Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Therapeutic indications:
An electrochemiluminescence immunoassay ?ECLIA? intended for use on Elecsys and cobas e immunoassay analyzers for the in vitro quantitative determination of IgG antibodies to Cytomegalovirus. Immunoassay for the in vitro quantitative determination of IgG antibodies to Cytomegalovirus in human serum and plasma, for diagnostic use and screening of blood donations.
Authorization status:
A
Authorization date:
2018-11-01
