Singclean

Primary DI

06936020140744

Basic UDI-DI Code

B-06936020140744

Reference

MA-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 Malaria antigen test kit (Immunochromatography) is a rapid chromatographic immunoassay for the qualitative detection of circulating plasmodium falciparum (P.f.) and Pan-malaria antigens (P.f., P.v., P.o. and P.m.) in whole blood. [INTRODUCTION] Malaria is caused by a protozoan which invades human red blood cells Malaria is one of the world's most prevalent diseases According to the WHO, the worldwide prevalence of the disease is estimated to be 300-500 million cases and over 1 million deaths each year. Most of these victims are infants, young children. Over half of the world's population lives in malarious areas. Microscopic analysis of appropriately stained thick and thin blood smears has been the standard diagnostic technique for identifying malaria infections for more than a century. The technique is capable of accurate and reliable diagnosis when performed by skilled microscopists using defined protocols. The skill of the microscopists and use of proven and defined procedures, frequently present the greatest obstades to fully achieving the potential accuracy of microscopic diagnosis. Although there is a logistical burden associated with performing a time-intensive, labor-intensive, and equipment-intensive procedure such as diagnostic microscopy, it is the training required to establish and sustain competent performance of microscopy that poses the greatest difficulty in employing this diagnostic technology. The Malaria antigen test kit (Immunochromatography) is a rapid test to qualitatively detect the presence of P falciparum-specific-HRP and Pan-LDH (Pan). The test utilizes colloid gold conjugate to selectively detect P.f-specific and Pan-LDH (Pan)-specific antigens in whole blood.

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