ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test

Primary DI

06936155804467

Basic UDI-DI Code

B-06936155804467

Reference

ITP71002

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

No Longer On The Market

Manufacturer

InTec PRODUCTS, INC.

The One Step Anti-Dengue (lgM& lgG) Tri-Line Test is ac olloidal gold enhanced, rapid immunochromatographic assay for the qualitative detection of antibodies (lgM& lgG) to dengue virus (DV) in human whole blood,serum or plasma. 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 using more specific alternative diagnosis methods to make final decision. This test is as creening test, and all positives must be confirmed using an alternate test. The test is intended for healthcare professional use only

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