Taiwan FDA registration f4b975fd5ba334360d41ea54acde3c29
Bioken Knaville Influenza Rapid Test Kit is the second generation
TW: 生研快納威流行性感冒快速檢驗套組第二代
Taiwan·Risk Class 2·DENKA CO., LTD·Registered Mar 22, 2021 – Mar 22, 2026ExpiredRegistration details
- Analysis ID
- f4b975fd5ba334360d41ea54acde3c29
- Customs Code
- DHA05603437508
Company information
- Manufacturer
- DENKA CO., LTD
- Manufacturer Country
- Japan
- Authorized Representative
- TUNYEN ENTERPRISE CORPORATION
Product details
- Intended Use
- Qualitative testing for influenza A virus antigen or influenza B virus antigen in nasopharyngeal swabs, nasal aspirates, or throat swabs (useful for diagnosing influenza virus infection).
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); C.3328 Influenza virus antigen rapid test system
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Mar 22, 2021
- Expiry Date
- Mar 22, 2026
About this record
Access comprehensive regulatory information for Bioken Knaville Influenza Rapid Test Kit is the second generation in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f4b975fd5ba334360d41ea54acde3c29 and manufactured by DENKA CO., LTD. The authorized representative in Taiwan is TUNYEN ENTERPRISE CORPORATION.
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