Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test
Basic Information
- Primary DI
- 06936155804504
- Basic UDI-DI Code
- B-06936155804504
- Reference
- ITP71004-TC20
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- InTec PRODUCTS, INC.
Additional Description
The Rapid Dengue Duo(NS1 Ag&IgM/IgG Ab) Test is a colloidal gold enhanced, rapid immunochromatographic assay for the qualitative detection of both dengue virus NS1 Ag and IgM&IgG antibodies to dengue virus(DV) in human whole blood, serum or plasma, and serves as an aid in the diagnosis of Dengue infections. It only provides preliminary analysis results but not critical diagnosis criteria, the obtained results should be analyzed in connection with other clinical information, e.g. clinical symptoms, and using more specific alternative diagnosis methods to make final decision. The test is a screening testm, and all postive must be confirmed using an alternate test. The test is intended for healthcare professional only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099007 | DENGUE - RT & POC |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).