Clinical Chemistry IVDs

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Mevcut itibaren:

Proteomics International Pty Ltd

Sınıf:

Class 1

Tarafından üretildi:

Proteomics International Pty Ltd 6 Verdun Street, Nedlands, WA, 6009 Australia

Terapötik alanı:

CT287 - Clinical Chemistry IVDs

Terapötik endikasyonlar:

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.

Yetkilendirme durumu:

A

Yetkilendirme tarihi:

2020-03-04