"Fei Qu" fecal occult blood immunoassay rapid test reagent - Taiwan Registration c44efb5364f61bc6150a50d8c3c8b927
Access comprehensive regulatory information for "Fei Qu" fecal occult blood immunoassay rapid test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c44efb5364f61bc6150a50d8c3c8b927 and manufactured by Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory. The authorized representative in Taiwan is Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory.
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Device Details
Product Details
The purpose of this product is to detect human heme (hHb) in stool samples in a rapid and qualitative manner. Gastrointestinal bleeding results in human heme (hHb) in a stool sample, and a small amount of bleeding that is not visible to the naked eye is called fecal occult blood (FOB). A positive result indicates the presence of human heme (hHb) in the sample. Clinically, the relevance of the patient's history to other diagnostic information also needs to be considered in parallel to evaluate the cause of fecal occult blood; A negative result does not completely rule out the possibility of fecal occult blood. This product is intended for use by professionals only and can assist in the detection of minor bleeding from the lower gastrointestinal tract.
B Hematology, pathology, and genetics
B.6550 Occult blood test
QMS/QSD;; ๅ็ข
Dates and Status
Oct 30, 2024
Oct 30, 2029