Malaria P.Falciparum/P.Vivax Rapid Test Kit（Colloidal Gold）

Trade name

Malaria P.Falciparum/P.Vivax Rapid Test Kit（Colloidal Gold）

UDI-DI code

06976374752408

Basic UDI-DI

B-06976374752408

Reference / catalog number

25 tests / kit（DR045-4）

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The reagent is used to detect the Malaria Plasmodium falciparum, Plasmodium vivax in whole blood qualitatively.Malaria is an insect borne disease caused by the infection of malaria parasites through the bite of Anopheles mosquitoes or the blood input of people with malaria parasites. It is widely distributed in tropical, subtropical and temperate marginal areas. About 300million people worldwide are infected every year, and about 3million people die, mainly children under 5 years old. More than half of the world's population lives in malaria endemic areas, and malaria has become one of the most serious global public health problems. There are four kinds of Plasmodium parasitizing human body, namely Plasmodium vivax (P.v), Plasmodium malariae (p.m), Plasmodium falciparum (P.f) and Plasmodium ovale (P.O). In China, Plasmodium vivax and Plasmodium falciparum are the main species, while the other two are rare. In recent years, some cases imported from abroad have occasionally been seen.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105090401PLASMODIUM (MALARIA) - RT & POC

No certificate specifically references this device's Basic UDI-DI.