PreciControl Anti-HBc IgM - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Offentlige vurderingsrapport
(PAR)
26-05-2019
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Tilgængelig fra:
Roche Diagnostics Australia Pty Limited
Klasse:
Class 4
Fremstillet af:
Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany
Terapeutisk område:
41982 - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Terapeutiske indikationer:
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.
Autorisation status:
A
Autorisation dato:
2018-12-07
