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“Quidel” Sofia hCG FIA - Taiwan Registration dee5a05586259e6d2222647fc20ec6d8

Access comprehensive regulatory information for “Quidel” Sofia hCG FIA in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number dee5a05586259e6d2222647fc20ec6d8 and manufactured by QUIDEL CORPORATION. The authorized representative in Taiwan is GRAND MARQUIS CO., LTD..

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dee5a05586259e6d2222647fc20ec6d8
Registration Details
Taiwan FDA Registration: dee5a05586259e6d2222647fc20ec6d8
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Device Details

“Quidel” Sofia hCG FIA
TW: “會得”舒妃雅人類絨毛膜促性腺激素快速螢光酵素免疫分析檢測套組
Risk Class 2
MD

Registration Details

dee5a05586259e6d2222647fc20ec6d8

Ministry of Health Medical Device Import No. 028467

DHA05602846701

Company Information

United States

Product Details

This product uses immunofluorescence lateral flow technology to qualitatively detect human chorionic gonadotropin (hCG) in urine, which helps to detect pregnancy early. It is required to be used with a Sofia analyzer.

A Clinical chemistry and clinical toxicology

A1155 Human chorionic gonadotropin test system

Imported from abroad

Dates and Status

Aug 01, 2016

Aug 01, 2026