cobas HBV/HCV/HIV-1 Control Kit for use on the cobas 4800 System - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
Izvješće o ocjeni javnog
(PAR)
22-11-2017
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Dostupno od:
Roche Diagnostics Australia Pty Limited
Razred:
Class 4
Proizveden od:
Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany
Područje terapije:
48218 - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Terapijske indikacije:
cobas HBV/HCV/HIV-1 Control Kit contains a Low Positive control, High Positive control and Negative control and is to be used as a batch control for the cobas HBV, cobas HCV, and cobas HIV-1 tests for use on the cobas 4800 System (nucleic acid technique). cobas HBV/HCV/HIV-1 Control Kit is used for the quality control of the cobas HBV, cobas HCV, and cobas HIV-1 tests for use on the cobas 4800 System.
Status autorizacije:
A
Datum autorizacije:
2017-09-18
