PreciControl HIV Gen II - HIV1/HIV2 antigen/antibody IVD, control
Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
Izvješće o ocjeni javnog
(PAR)
28-05-2019
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Pošalji zahtjev.
Pošalji zahtjev.
Dostupno od:
Roche Diagnostics Australia Pty Limited
Razred:
Class 4
Proizveden od:
Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany
Područje terapije:
48449 - HIV1/HIV2 antigen/antibody IVD, control
Terapijske indikacije:
PreciControl HIV Gen II is a lyophilized control serum based on human serum. The control levels 1, 2 and 3 are used for monitoring the accuracy of the Elecsys HIV combi PT and Elecsys HIV Duo assays. The control levels 1 and 3 are used for monitoring the accuracy of the Elecsys HIV Ag assay. PreciControl HIV Gen II is used for quality control of the Elecsys HIV combi PT, Elecsys HIV Duo and Elecsys HIV Ag immunoassays on the Elecsys and cobas e immunoassay analysers
Status autorizacije:
A
Datum autorizacije:
2018-05-18
