Taiwan FDA registration c44efb5364f61bc6150a50d8c3c8b927

"Fei Qu" fecal occult blood immunoassay rapid test reagent

TW: "飛確" 糞便潛血免疫法快速檢驗試劑
Taiwan flagTaiwan·Risk Class 2·Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory·Registered Oct 30, 2024 – Oct 30, 2029Active
Registration details
Analysis ID
c44efb5364f61bc6150a50d8c3c8b927
Company information
Manufacturer Country
Taiwan, Province of China
Product details
Intended Use
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.
Product Type (Level 1)
B Hematology, pathology, and genetics
Product Type (Level 2)
B.6550 Occult blood test
Import Information
QMS/QSD;; 國產
Dates and status
Registration Date
Oct 30, 2024
Expiry Date
Oct 30, 2029
About this record

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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