Taiwan FDA registration 998e544eb57fcadc234f4346ce4995d1

"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

Taiwan·Risk Class 3·MAGQU CO., LTD.·Registered Dec 08, 2020 – Dec 08, 2025Expired

Registration details

Analysis ID: 998e544eb57fcadc234f4346ce4995d1

Company information

Manufacturer: MAGQU CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: MAGQU CO., LTD.

Product details

Intended Use: 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.
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 1-42 (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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