Prostate specific marker IVDs

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos Javno poročilo o oceni (PAR)
10-11-2017

Dostopno od:

Beckman Coulter Australia Pty Ltd

Razred:

Class 3

Izdeluje:

Beckman Coulter Inc 250 South Kraemer Boulevard, Brea, CA, 92821 United States Of America

Terapevtsko območje:

CT846 - Prostate specific marker IVDs

Terapevtske indikacije:

Access Hybritech p2PSA kit, controls and calibrators are a paramagnetic particle, chemiluminescent assay used in combination with the Access Hybritech PSA and free PSA assays to calculate the Beckman Coulter phi, a multivariate index, intended to aid the determination of the risk of prostate cancer using human serum on the Access Immunoassay Systems.

Status dovoljenje:

A

Datum dovoljenje:

2013-10-18

Opozorila o iskanju, povezana s tem izdelkom