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Rapid detection reagent for influenza virus antigen - Taiwan Registration c79bf49da58fc14f1e272ad182f77642

Access comprehensive regulatory information for Rapid detection reagent for influenza virus antigen in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c79bf49da58fc14f1e272ad182f77642 and manufactured by SD BIOSENSOR, Inc.. The authorized representative in Taiwan is CREATIVE LIFE SCIENCE CO., LTD..

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c79bf49da58fc14f1e272ad182f77642
Registration Details
Taiwan FDA Registration: c79bf49da58fc14f1e272ad182f77642
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Device Details

Rapid detection reagent for influenza virus antigen
TW: ้€Ÿๅพ—็™พๆฃฎๆต่กŒๆ€งๆ„Ÿๅ†’็—…ๆฏ’ๆŠ—ๅŽŸๅฟซ้€Ÿๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 2

Registration Details

c79bf49da58fc14f1e272ad182f77642

DHA05603463702

Company Information

Korea, Republic of

Product Details

The Speedbasen Influenza Virus Antigen Test is an immunofluorescence analysis to detect the nucleoprotein antigens of influenza A and B viruses in the human nasopharynx. IT IS ALSO USED WITH STANDARD F FLUORESCENCE ANALYZER (MANUFACTURED BY SD BIOSENSOR) FOR INTERPRETATION ANALYSIS, PROFESSIONAL USE AND EARLY RAPID SCREENING.

C Immunology and microbiology

C.3328 Influenza Virus Antigen Rapid Screening and Detection System

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Apr 28, 2021

Apr 28, 2026