PreciControl Anti-HBc IgM - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
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:
41982 - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Therapeutic indications:
PreciControl Anti HBc IgM 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 HBc IgM immunoassay. PreciControl Anti HBc IgM is used for quality control of the Elecsys Anti HBc IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.
Authorization status:
A
Authorization date:
2018-12-07
