PreciControl Anti-HBc IgM - Hepatitis B virus core immunoglobulin M (IgM) antibody 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:

41982 - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

therapeutic_indication:

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