PLASMODIUM (MALARIA) - RT & POC

Primary DI

06936791020092

Basic UDI-DI Code

B-06936791020092

Reference

EX0402-25

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhongshan Bio-Tech Co., Ltd.

This product is intended for use of the in vitro qualitative test of the plasmodium falciparum HRP-II in human venous blood. As an insect-borne infectious disease that seriously destroys human health, malaria is not only a widespread disease in some developing countries in tropical and subtropical areas, but also one of the most dreadful infections that threaten people's health. HRP-II is the water-soluble antigen containing a large amount of histidine synthesized and secreted by the plasmodium falciparum to the blood. It exists in the gametophyte at the asexual blood stage and early stage and its content will rise gradually with the division of merozoites during the whole red blood cell period. HRP-II is also the only protein known so far to be released from fully infected red blood cells in plasmodium falciparum, while the rest of the proteins are mostly secreted when agamonts proliferate causing red blood cells to rupture and merozoites are released. HRP-II is high in the serum of infected organisms, has species specificity and is an exposed antigenic component, and is considered to be an ideal specific diagnostic target antigen for falciparum malaria, so the detection of this antigen is important for the rapid diagnosis of falciparum malaria.

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