ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)

Primary DI

06974521001867

Basic UDI-DI Code

B-06974521001867

Reference

SUPG021025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

The ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold) is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-Dengue IgG , anti-Dengue IgM and Dengue NS1 antigen (DEN1, 2, 3, 4) in human serum, plasma or whole blood. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with Dengue virus. Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.

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