PreciControl HIV Gen II - HIV1/HIV2 antigen/antibody IVD, control
Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Offentlige vurderingsrapport
(PAR)
28-05-2019
Nogle dokumenter til dette produkt er ikke tilgængelige i øjeblikket, du kan sende en anmodning til vores kundeservice, og vi vil underrette dig, så snart vi er i stand til at få dem.
Send anmodning.
Send anmodning.
Tilgængelig fra:
Roche Diagnostics Australia Pty Limited
Klasse:
Class 4
Fremstillet af:
Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany
Terapeutisk område:
48449 - HIV1/HIV2 antigen/antibody IVD, control
Terapeutiske indikationer:
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
Autorisation status:
A
Autorisation dato:
2018-05-18
