PreciControl HIV Gen II - HIV1/HIV2 antigen/antibody IVD, control

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

זמין מ:

Roche Diagnostics Australia Pty Limited

סיווג:

Class 4

תוצרת:

Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany

איזור תרפויטי:

48449 - HIV1/HIV2 antigen/antibody IVD, control

סממני תרפויטית:

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

מצב אישור:

A

תאריך אישור:

2018-05-18