Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
DENGUE - RT & POC
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06975445472061
- Basic UDI-DI Code
- B-06975445472061
- Reference
- Dengue Rapid Test Kit (Colloidal Gold Method)
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- FARMASINO MEDICAL CO., LTD
Additional Description
The Dengue NS1 Rapid Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of dengue virus antigen (Dengue Ag) 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 NS1 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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