RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

Primary DI

06930317801462

Basic UDI-DI Code

B-06930317801462

Reference

DNK-2301-1

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Dynamiker Biotechnology (Tianjin) Co., Ltd.

This product is intended for quantitative determination of the content of (1 3)-β-D-Glucan in human serum or plasma samples. (1-3)-β-D-Glucan is a component of the cell walls of many pathogenic fungi (except zygomycetes and crypotococcus), and is a unique marker of fungi. When the blood and deep tissues of the human body are invaded by fungi, (1-3)-β-D-Glucan derived from the fungal cell wall is phagocytosed and digested by phagocytes and can be released from the fungal cell wall into blood and other body fluids. Therefore, (1-3)-β-D-Glucan can be used for the early diagnosis of invasive fungal infections

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).