ONE STEP H. pylori Ag Test

Primary DI

06936155804429

Basic UDI-DI Code

B-06936155804429

Reference

ITP10003-DS50

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

InTec PRODUCTS, INC.

ONE STEP H.PYLOR! Ag Test is a rapid, serological, immunochromatographicassay for the detection of helicobacter pylori antigen (hp)in human fecessample.The test is used to obtain a visual, qualitative result. 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 alterate test to make final decision. The test isintended for healthcare professional use.

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