PreciControl HIV; HIV-2+GrpO - HIV1/HIV2 antigen/antibody IVD, control

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
28-05-2019

Dostopno od:

Roche Diagnostics Australia Pty Limited

Razred:

Class 4

Izdeluje:

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

Terapevtsko območje:

48449 - HIV1/HIV2 antigen/antibody IVD, control

Terapevtske indikacije:

PreciControl HIV; HIV-2+GrpO is a lyophilized control serum based on human serum. The controls are used for monitoring the accuracy of the Elecsys HIV combi PT and Elecsys HIV Duo assays. PreciControl HIV; HIV-2GrpO is used for quality control of the Elecsys HIV combi PT and Elecsys HIV Duo immunoassays on the Elecsys and cobas e immunoassay analysers

Status dovoljenje:

A

Datum dovoljenje:

2018-05-18

Opozorila o iskanju, povezana s tem izdelkom