PreciControl HBsAg II - Hepatitis B virus surface antigen IVD, control

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

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_indication:

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