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
Taiwan flagTaiwan·Risk Class 2·QUIDEL CORPORATION·Registered Oct 05, 2020 – Oct 05, 2025Expired
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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