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"QuickProfit" Speedfly Influenza Virus A and B Fluorescence Immunoassay Kit - Taiwan Registration 3c85826b8cb215beba4efdbd2f193808

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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3c85826b8cb215beba4efdbd2f193808
Registration Details
Taiwan FDA Registration: 3c85826b8cb215beba4efdbd2f193808
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Device Details

"QuickProfit" Speedfly Influenza Virus A and B Fluorescence Immunoassay Kit
TW: โ€œๅฟซๅพ—ๅˆฉโ€ ้€Ÿ้ฃ›็ˆพๆต่กŒๆ€งๆ„Ÿๅ†’็—…ๆฏ’Aๅž‹ๅ’ŒBๅž‹่žขๅ…‰ๅ…็–ซๅˆ†ๆžๆชขๆธฌๅฅ—็ต„
Risk Class 2

Registration Details

3c85826b8cb215beba4efdbd2f193808

DHA05603368202

Company Information

United States

Product Details

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.

C Immunology and microbiology

C.3328 Influenza Virus Antigen Rapid Screening and Detection System

Input;; QMS/QSD

Dates and Status

Oct 05, 2020

Oct 05, 2025