VIROLOGY - RT & POC - OTHER

Primary DI

06975445472115

Basic UDI-DI Code

B-06975445472115

Reference

Human Fecal Occult Blood (FOB) Rapid Test Kit

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

FARMASINO MEDICAL CO., LTD

death in the United States. Screening for colorectal cancer probably increases the cancer detection at an early stage, therefore reduces the mortality. Earlier commercially available FOB tests utilized the guaiac test, which requires special dietary restriction to minimize false positive and false negative results. The FOB Rapid Test Kit (Feces) are especially designed to detect human hemoglobin in fecal samples using Immunochemical methods, which improved specificity for the detection of lower gastrointestinal disorders, including colorectal cancers and adenomas.

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