Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Dengue IgG/IgM Rapid Test Device
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06939663977883
- Basic UDI-DI Code
- B-06939663977883
- Reference
- Cassette
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Sejoy Biomedical Co., Ltd.
Additional Description
The Dengue IgG/IgM Rapid Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of dengue IgG/ IgM in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Dengue viruses. Any reactive specimen with the Dengue IgG/IgM Rapid Test Device must be confirmed with alternative testing method(s) and clinical findings..
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099007 | DENGUE - RT & POC |
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