Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Bio·Firm
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-WI-MICR-C43A-25A3
- Basic UDI-DI Code
- B-WI-MICR-C43A-25A3
- Reference
- WI-MICR-C43A-25
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Zhejiang Wantaifu Biotechnology Co., Ltd
Additional Description
Dengue IgG/IgM and NS1 Rapid Test Device is a solid phase immunochromatographic assay for the qualitative and differential detection of IgG and IgM antibodies to dengue virus and NS1 antigen of Dengue virus in human serum, plasma or whole blood. This test is intended for professional use as an aid in the presumptive diagnosis between primary and secondary dengue infection. This test provides only a preliminary test result. Therefore, a more specific diagnosis method must be used in order to obtain a confirmation of dengue virus infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099007 | DENGUE - RT & POC |
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