Clinical Chemistry IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
28-05-2020
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Available from:
Proteomics International Pty Ltd
Class:
Class 1
Manufactured by:
Proteomics International Pty Ltd 6 Verdun Street, Nedlands, WA, 6009 Australia
Therapeutic area:
CT287 - Clinical Chemistry IVDs
Therapeutic indications:
PromarkerD (MS) is an in vitro quantitative test intended for the detection of three protein biomarkers (analytes) in human plasma. This quantitative test result together with three clinical variables are intended to enter into an algorithm (PromarkerD Hub) to generate the prognosis and diagnosis risk scores of diabetic kidney disease (DKD) in patients with type 2 diabetes. The test is designed to be used by clinical laboratory trained personal.
Authorization status:
A
Authorization date:
2020-03-04
