Fecal Occult Blood Rapid Test Cassette (Feces)

Primary DI

06950996002448

Basic UDI-DI Code

B-06950996002448

Reference

GEFOB-602b

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 (FOB) Rapid Test Cassette (Feces) is a rapid test to qualitatively detect low levels of fecal occult blood in feces. The test uses double antibod- sandwich assay to selectively detect as low as 50ng/mL of hemoglobin or 6ug 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).