Singclean

Primary DI

06936020140676

Basic UDI-DI Code

B-06936020140676

Reference

FOB-02-20t

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou Singclean Medical Products Co., Ltd.

[INTENDED USE] Fecal Occult Blood Test Kit (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative determination of Fecal Occult Blood. It is used for the aid to early diagnosis of gastrointestinal bleeding. [INTRODUCTION] Fecal occult blood refers to a small amount of bleeding from the digestive tract, red blood cells are destroyed by digestion, and there is no abnormal change in the appearance of the stool, which cannot be confirmed by the naked eye or microscopy. In the early stage of clinical gastrointestinal malignancy, 20% of patients can have a positive fecal occult blood test, and the positive rate of fecal occult blood in advanced patients can reach more than 90%, and it can be persistently positive, gastrointestinal bleeding, and fecal occult blood test in patients with peptic ulcer is mostly intermittently positive. Dysentery, rectal polyps, hemorrhoidal bleeding, etc. can also cause more red blood cells to appear in the stool, resulting in a positive fecal occult blood test. Therefore, fecal occult blood test can be used as an important test for the detection of gastrointestinal bleeding caused by various causes and the early screening of gastrointestinal malignant tumors, and is an effective method to detect fecal occult blood.

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