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

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
28-05-2019

Saadav alates:

Roche Diagnostics Australia Pty Limited

Klass:

Class 4

Valmistatud:

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

Terapeutiline ala:

48449 - HIV1/HIV2 antigen/antibody IVD, control

Näidustused:

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

Volitamisolek:

A

Loa andmise kuupäev:

2018-05-18

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