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禮雅尚EB病毒核抗原 IgG 檢測試劑-品管液 - Taiwan Registration 99cc9cce45d7236fe4b9173fbd5461e3

Access comprehensive regulatory information for 禮雅尚EB病毒核抗原 IgG 檢測試劑-品管液 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 99cc9cce45d7236fe4b9173fbd5461e3 and manufactured by DIASORIN ITALIA S.P.A.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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99cc9cce45d7236fe4b9173fbd5461e3
Registration Details
Taiwan FDA Registration: 99cc9cce45d7236fe4b9173fbd5461e3
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Device Details

禮雅尚EB病毒核抗原 IgG 檢測試劑-品管液
Risk Class 2

Registration Details

99cc9cce45d7236fe4b9173fbd5461e3

DHA05603706202

Company Information

Italy

Product Details

This product is tested by CLIA Chemiluminescence Immunoassay (CLIA) as a reagent for EBV nuclear antigen IgG detection in the Leyson XL Analyzer and the LeyElegance XS Analyzer.

A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical)

QMS/QSD;; 輸入

Dates and Status

Feb 22, 2024

Feb 22, 2029