PreciControl Anti-HBc II - Hepatitis B virus core total antibody IVD, control
Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
Javno poročilo o oceni
(PAR)
28-05-2019
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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:
41984 - Hepatitis B virus core total antibody IVD, control
Terapevtske indikacije:
PreciControl Anti - HBc II 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 II immunoassay. PreciControl Anti - HBc II is used for quality control of the Elecsys Anti - HBc II immunoassay on the Elecsys and cobas e immunoassay analysers.
Status dovoljenje:
A
Datum dovoljenje:
2017-12-22
