Taiwan FDA registration 27a99d3997385dff4398476be140692a

"Fly Que" A+B influenza rapid test reagent

TW: "飛確" A+B型流行性感冒快速檢驗試劑

Taiwan·Risk Class 2·Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory·Registered Aug 18, 2020 – Aug 18, 2025Expired

Registration details

Analysis ID: 27a99d3997385dff4398476be140692a

Company information

Manufacturer: Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: PANION & BF BIOTECH INC.

Product details

Intended Use: 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.
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;; 國產

Dates and status

Registration Date: Aug 18, 2020
Expiry Date: Aug 18, 2025

About this record

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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