PreciControl Anti-HCV (cobas e 411/601/602) - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
Javno poročilo o oceni
(PAR)
22-11-2017
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Dostopno od:
Roche Diagnostics Australia Pty Limited
Razred:
Class 4
Izdeluje:
Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany
Terapevtsko območje:
41973 - Hepatitis C virus total antibody IVD, control
Terapevtske indikacije:
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.
Status dovoljenje:
A
Datum dovoljenje:
2013-09-13
