PreciControl Anti-HCV (cobas e 411/601/602) - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Compra

Commercializzato da:

Roche Diagnostics Australia Pty Limited

Classe:

Class 4

Prodotto da:

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

Area terapeutica:

41973 - Hepatitis C virus total antibody IVD, control

Indicazioni terapeutiche:

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

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2013-09-13

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