ONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold)

Primary DI

06974521001928

Basic UDI-DI Code

B-06974521001928

Reference

SUPG017025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

The ONE STEP Malaria P.F/P.V Tri-line Rapid Test (Colloidal Gold) is a rapid, immunochromatographic assay for the qualitative detection of the specific soluble protein, histidine-rich protein Ⅱ(pf HRP Ⅱ) and pvLDH which is present in, and released from, infected red blood cells. The presence of pf HRP Ⅱ and pv LDH can be detected within 15 minutes at the concentration of 200para/µl or higher. The assay does not require additional instruments. This test is a rapid test as an aid in the diagnosis of relative infection and relative symptom; it only provides preliminary analysis results but not critical diagnosis criteria, the obtained results should be analyzed in connection with other clinical information, e.g. clinical symptoms, and alternate test to make final decision.

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