RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- 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.
Additional Description
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
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021699 | RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).