PreciControl Anti-HBc II - Hepatitis B virus core total antibody IVD, control
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
28-05-2019
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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:
41984 - Hepatitis B virus core total antibody IVD, control
Therapeutic indications:
PreciControl Anti - HBc II 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 II immunoassay. PreciControl Anti - HBc II is used for quality control of the Elecsys Anti - HBc II immunoassay on the Elecsys and cobas e immunoassay analysers.
Authorization status:
A
Authorization date:
2017-12-22
