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Roche immunoassay β amyloid (1-42) cerebrospinal fluid II test reagents - Taiwan Registration 59d761631f733742b45559d443f73767

Access comprehensive regulatory information for Roche immunoassay β amyloid (1-42) cerebrospinal fluid II test reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 59d761631f733742b45559d443f73767 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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59d761631f733742b45559d443f73767
Registration Details
Taiwan FDA Registration: 59d761631f733742b45559d443f73767
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Device Details

Roche immunoassay β amyloid (1-42) cerebrospinal fluid II test reagents
TW: 羅氏免疫分析β類澱粉蛋白(1-42)腦脊髓液 II 檢驗試劑
Risk Class 3

Registration Details

59d761631f733742b45559d443f73767

DHA05603622907

Company Information

Germany

Product Details

This product is used to quantify the concentration of β-amyloid (1-42) (β-Amyloid) in human cerebrospinal fluid by electrochemiluminescence immunoassay (ECLIA) in vitro.

A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology

A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; C.9999 Miscellaneous

QMS/QSD;; 輸入

Dates and Status

Oct 16, 2023

Oct 16, 2028