Dengue IgGIgM and NS1 Rapid Test Device (whole blood/serum/plasma)

Primary DI

06976753473375

Basic UDI-DI Code

B-06976753473375

Reference

A240501D

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou Cybereagen Biotech Co., Ltd.

Dengue IgGIgM and NS1 Rapid Test Device (whole blood/serum/plasma) 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.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).