PreciControl Anti-HBs - Hepatitis B virus surface total antibody IVD, control

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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PAR PAR (PAR)
09-06-2019

MAH:

Roche Diagnostics Australia Pty Limited

class:

Class 4

manufactured_by:

Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany

therapeutic_area:

41998 - Hepatitis B virus surface total antibody IVD, control

therapeutic_indication:

PreciControl Anti-HBs 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-HBs II immunoassays. PreciControl Anti-HBs is used for quality control of the Elecsys Anti-HBs II immunoassays on the Elecsys and cobas e immunoassay analyzers.

authorization_status:

A

authorization_date:

2019-06-06