Prostate specific marker IVDs

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Beckman Coulter Australia Pty Ltd

classe:

Class 3

Fabriqué par:

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

Domaine thérapeutique:

CT846 - Prostate specific marker IVDs

indications thérapeutiques:

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.

Statut de autorisation:

A

Date de l'autorisation:

2013-10-18