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"Magnetic" beta amyloid 1-42 (Aβ1-42) immunomagnetic reduction detection reagent - Taiwan Registration 998e544eb57fcadc234f4346ce4995d1

Access comprehensive regulatory information for "Magnetic" beta amyloid 1-42 (Aβ1-42) 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 998e544eb57fcadc234f4346ce4995d1 and manufactured by MAGQU CO., LTD.. The authorized representative in Taiwan is MAGQU CO., LTD..

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998e544eb57fcadc234f4346ce4995d1
Registration Details
Taiwan FDA Registration: 998e544eb57fcadc234f4346ce4995d1
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Device Details

"Magnetic" beta amyloid 1-42 (Aβ1-42) immunomagnetic reduction detection reagent
TW: “磁量”乙型澱粉樣蛋白1-42(Aβ1-42)免疫磁減量檢測試劑
Risk Class 3

Registration Details

998e544eb57fcadc234f4346ce4995d1

Company Information

Taiwan, Province of China

Product Details

The efficacy has been changed to: This product can only be used as one of the reference materials for the clinical diagnosis of Alzheimer's disease, and the results of this test cannot be used as the only basis for confirmation. This product uses immunomagnetic reduction analysis to quantitatively detect the concentration of Aβ1-42 protein in human plasma, or the ratio of its concentration to the "magnetic amount" Tau protein immunomagnetic reduction test dose test concentration (Aβ1-42 x Tau) or "magnetic amount" beta amyloid 1-40 (Aβ1-40) immunomagnetic reduction test dose concentration (Aβ1-42/Aβ1-40) As a test value, it needs to be combined with clinical data and other test results as a reference to help diagnose Alzheimer's disease.

C Immunology and microbiology

C.9999 Miscellaneous

QMS/QSD;; 國產

Dates and Status

Dec 08, 2020

Dec 08, 2025