Prostate specific marker IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
10-11-2017
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Available from:
Beckman Coulter Australia Pty Ltd
Class:
Class 3
Manufactured by:
Beckman Coulter Inc 250 South Kraemer Boulevard, Brea, CA, 92821 United States Of America
Therapeutic area:
CT846 - Prostate specific marker IVDs
Therapeutic indications:
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.
Authorization status:
A
Authorization date:
2013-10-18
