Rapid FOB Test

Primary DI

06936155804443

Basic UDI-DI Code

B-06936155804443

Reference

ITP13001-DS50

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

No Longer On The Market

Manufacturer

InTec PRODUCTS, INC.

The FOB Test is a rapid,serological immunochromatographic assay for the detection of hemoglobin (hb) in human feces. 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 alternate test to make final decision. The test isintended for healthcare professional use.

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