Singclean

Primary DI

06936020140829

Basic UDI-DI Code

B-06936020140829

Reference

DEN-02-10t

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou Singclean Medical Products Co., Ltd.

[INTENDED USE] The Dengue Test Kit (Immunochromatography) is a rapid chromatographic immunoassay for the qualitative detection of Dengue virus antigen in human whole blood, serum, or plasma. For professional use only. [INTRODUCTION] Dengue viruses, transmitted by the mosquito, Aedes aegypti and Aedes albopictus mosquitoes, are widely distributed throughout the tropical and subtropical areas of the world. There are four known distinct serotypes (Dengue virus 1, 2, 3 and 4). In children, infection is often subclinical or causes a self-limited febrile disease. However, if the patient is infected second times with a different serotype, a more severe disease, Dengue hemorrhagic fever or Dengue shock syndrome, is more likely to occur. Dengue is considered to be the most important arthropod-borne viral disease due to the human morbidity and mortality it causes. Dengue is a highly-conserved glycoprotein that is present at high concentrations in the sera of Dengue-infected patients during the early clinical phase of the disease. antigen is found from the first day and up to 9 days after onset of fever in sample of primary or secondary Dengue infected patients.

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