PreciControl HBsAg II - Hepatitis B virus surface antigen IVD, control
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:
42000 - Hepatitis B virus surface antigen IVD, control
Therapeutic indications:
A ready to use control serum based on human serum both in the negative and positive concentration range. For quality control of the Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm immunoassays on the Elecsys and cobas e immunoassay analysers.
Authorization status:
A
Authorization date:
2013-09-13
