Bioken Knaville Influenza Rapid Test Kit is the second generation - Taiwan Registration f4b975fd5ba334360d41ea54acde3c29
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.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Product Details
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).
A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
A.1660 Quality control materials (analytical and non-analytical); C.3328 Influenza virus antigen rapid test system
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Mar 22, 2021
Mar 22, 2026