Taiwan FDA registration 3c85826b8cb215beba4efdbd2f193808
"QuickProfit" Speedfly Influenza Virus A and B Fluorescence Immunoassay Kit
TW: “快得利” 速飛爾流行性感冒病毒A型和B型螢光免疫分析檢測套組
Registration details
- Analysis ID
- 3c85826b8cb215beba4efdbd2f193808
- Customs Code
- DHA05603368202
Company information
- Manufacturer
- QUIDEL CORPORATION
- Manufacturer Country
- United States
- Authorized Representative
- BIO-CHECK LABORATORIES LTD.
Product details
- Intended Use
- This product uses immunofluorescence staining to detect the antigens of influenza virus type A and B nucleoproteins in nasal swabs, nasopharyngeal swabs, nasopharyngeal aspiration fluids/irrigation solutions or transport media samples of symptomatic patients.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3328 Influenza Virus Antigen Rapid Screening and Detection System
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Oct 05, 2020
- Expiry Date
- Oct 05, 2025
About this record
Access comprehensive regulatory information for "QuickProfit" Speedfly Influenza Virus A and B Fluorescence Immunoassay Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3c85826b8cb215beba4efdbd2f193808 and manufactured by QUIDEL CORPORATION. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..
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