Taiwan FDA registration c79bf49da58fc14f1e272ad182f77642
Rapid detection reagent for influenza virus antigen
TW: 速得百森流行性感冒病毒抗原快速檢測試劑
Taiwan·Risk Class 2·SD BIOSENSOR, Inc.·Registered Apr 28, 2021 – Apr 28, 2026ExpiredRegistration details
- Analysis ID
- c79bf49da58fc14f1e272ad182f77642
- Customs Code
- DHA05603463702
Company information
- Manufacturer
- SD BIOSENSOR, Inc.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- CREATIVE LIFE SCIENCE CO., LTD.
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3328 Influenza Virus Antigen Rapid Screening and Detection System
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Apr 28, 2021
- Expiry Date
- Apr 28, 2026
About this record
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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