Taiwan FDA registration e259c3586adac214bb9755fa900644cc
"Magnetic" beta amyloid 1-40 (Aβ1-40) immunomagnetic reduction detection reagent
TW: “磁量”乙型澱粉樣蛋白1-40(Aβ1-40)免疫磁減量檢測試劑
Taiwan·Risk Class 3·MAGQU CO., LTD.·Registered Dec 08, 2020 – Dec 08, 2025ExpiredRegistration details
- Analysis ID
- e259c3586adac214bb9755fa900644cc
Company information
- Manufacturer
- MAGQU CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- MAGQU CO., LTD.
Product details
- Intended Use
- At present, this product can only be used as one of the reference materials for clinical diagnosis of Alzheimer's disease, and the results of this test cannot be used as the only basis for diagnosis. This product uses immunomagnetic reduction analysis to quantitatively detect the concentration of Aβ1-40 protein in human plasma, and its concentration value needs to be compared with the ratio of the "magnetic amount" beta amyloid 1-42 (Aβ1-42) immunomagnetic reduction test dose (Aβ1-42/Aβ1-40) as the detection value, and with clinical data and other test results, as a reference to assist in the diagnosis of Alzheimer's disease.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.9999 Miscellaneous
- Import Information
- QMS/QSD;; 國產
Dates and status
- Registration Date
- Dec 08, 2020
- Expiry Date
- Dec 08, 2025
About this record
Access comprehensive regulatory information for "Magnetic" beta amyloid 1-40 (Aβ1-40) immunomagnetic reduction detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number e259c3586adac214bb9755fa900644cc and manufactured by MAGQU CO., LTD.. The authorized representative in Taiwan is MAGQU CO., LTD..
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