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"Magnetic" beta amyloid 1-40 (Aβ1-40) immunomagnetic reduction detection reagent - Taiwan Registration e259c3586adac214bb9755fa900644cc

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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e259c3586adac214bb9755fa900644cc
Registration Details
Taiwan FDA Registration: e259c3586adac214bb9755fa900644cc
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Device Details

"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
Risk Class 3

Registration Details

e259c3586adac214bb9755fa900644cc

Company Information

Taiwan, Province of China

Product Details

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.

C Immunology and microbiology

C.9999 Miscellaneous

QMS/QSD;; 國產

Dates and Status

Dec 08, 2020

Dec 08, 2025