Filariasis IgG/IgM Rapid Test Device(Whole Blood/Serum/Plasma)

Primary DI

06976753475560

Basic UDI-DI Code

B-06976753475560

Reference

A390501D

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou Cybereagen Biotech Co., Ltd.

Filariasis IgG/IgM Rapid Test Device(Whole Blood/Serum/Plasma) is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-lymphatic filarial parasites (W. Bancrofti and B. Malayi ) 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 lymphatic filarial parasites. Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of the 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).