"Fly Que" A+B influenza rapid test reagent - Taiwan Registration 27a99d3997385dff4398476be140692a
Access comprehensive regulatory information for "Fly Que" A+B influenza rapid test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 27a99d3997385dff4398476be140692a and manufactured by Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory. The authorized representative in Taiwan is PANION & BF BIOTECH INC..
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Device Details
Product Details
This product uses in vitro immunochromatography to qualitatively detect whether patients with influenza symptoms have influenza A and B viruses through nasopharyngeal swabs, and influenza viruses can be detected at an early stage of symptoms. This product is intended for laboratory and professional use only to assist in the early diagnosis of influenza A and influenza B, and cannot detect influenza C. If this product results are negative, the diagnosis must still be confirmed by cell culture. A negative result does not exclude the possibility of influenza virus infection; therefore, test results should not be used as the sole basis for treatment or other measures.
C Immunology and microbiology
C.3328 Influenza Virus Antigen Rapid Screening and Detection System
QMS/QSD;; ๅ็ข
Dates and Status
Aug 18, 2020
Aug 18, 2025