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

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ixtrih issa

Disponibbli minn:

Roche Diagnostics Australia Pty Limited

Klassi:

Class 4

Manifatturat minn:

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

Żona terapewtika:

48449 - HIV1/HIV2 antigen/antibody IVD, control

Indikazzjonijiet terapewtiċi:

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

L-istatus ta 'awtorizzazzjoni:

A

Data ta 'l-awtorizzazzjoni:

2018-05-18

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