Taiwan FDA registration dee5a05586259e6d2222647fc20ec6d8
“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
Taiwan·Risk Class 2·MD·QUIDEL CORPORATION·Registered Aug 01, 2016 – Aug 01, 2026ActiveRegistration details
- Analysis ID
- dee5a05586259e6d2222647fc20ec6d8
- License Form
- Ministry of Health Medical Device Import No. 028467
- Customs Code
- DHA05602846701
Company information
- Manufacturer
- QUIDEL CORPORATION
- Manufacturer Country
- United States
- Authorized Representative
- GRAND MARQUIS CO., LTD.
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1155 Human chorionic gonadotropin test system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 01, 2016
- Expiry Date
- Aug 01, 2026
About this record
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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