Fecal Occult Blood Rapid Test Strip (Feces)

Primary DI

D-GEFOB-601bXG

Basic UDI-DI Code

B-GEFOB-601bXG

Reference

GEFOB-601b

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhejiang Orient Gene Biotech Co., Ltd

Most of diseases can cause hidden blood in the stool. In the early stages, gastrointestinal problems such as colon cancer, ulcers, polyps, colitis, diverticulitis, and fissures may not show any visible symptoms, only occult blood. Traditional guaiac-based method lacks sensitivity and specificity, and has diet-restriction prior to the testing. Fecal Occult Blood Rapid Test Strip (Feces) is a rapid test to qualitatively detect low levels of fecal occult blood in feces. The test uses doubleantibody-sandwich assay to selectively detect as low as 50ng/mL of hemoglobin or 6μg hemoglobin/g feces. In addition, unlike the guaiac assays, the accuracy of the test is not affected by the diet of the patients.

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