Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974521001898
- Basic UDI-DI Code
- B-06974521001898
- Reference
- SUPG020025-1
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Shenzhen Superbio Technology Co.,Ltd.
Additional Description
The test is assay for the qualitative detection of the Dengue NS1 antigen in human whole blood, plasma or serum samples. The test intended only as an initial diagnostic test, and all positives must be confirmed using an alternate test such as EIA. The test is intended for healthcare professional use only
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099007 | DENGUE - RT & POC |
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