Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Dengue NS1 Antigen Rapid Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06939663977890
- Basic UDI-DI Code
- B-06939663977890
- 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 NS1 Antigen Rapid Test 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 Antigen Rapid Test must be confirmed with alternative testing method(s) and clinical findings..
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099007 | DENGUE - RT & POC |
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