Taiwan FDA registration 70914c3e5031f690db8593d835af7b7d
“Quidel” Sofia Influenza A+B FIA
TW: “會得” 舒妃雅流行性感冒A型和B型快速螢光酵素免疫分析檢測套組
Taiwan·Risk Class 2·MD·QUIDEL CORPORATION·Registered Jul 01, 2020 – Jul 01, 2025ExpiredRegistration details
- Analysis ID
- 70914c3e5031f690db8593d835af7b7d
- License Form
- Ministry of Health Medical Device Import No. 033501
- Customs Code
- DHA05603350108
Company information
- Manufacturer
- QUIDEL CORPORATION
- Manufacturer Country
- United States
- Authorized Representative
- GRAND MARQUIS CO., LTD.
Product details
- Intended Use
- Immunofluorescence was used in conjunction with Sofia and Sofia 2 analyzers for the detection of influenza A and B antigens.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3328 Influenza Virus Antigen Rapid Screening System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 01, 2020
- Expiry Date
- Jul 01, 2025
About this record
Access comprehensive regulatory information for “Quidel” Sofia Influenza A+B FIA in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 70914c3e5031f690db8593d835af7b7d and manufactured by QUIDEL CORPORATION. The authorized representative in Taiwan is GRAND MARQUIS CO., LTD..
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