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Bionic Research Fast Neville Influenza and Respiratory Fusion Virus Rapid Test Kit - Taiwan Registration 78f10d87b0b4f9af82d07d12f3daadda

Access comprehensive regulatory information for Bionic Research Fast Neville Influenza and Respiratory Fusion Virus Rapid Test Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 78f10d87b0b4f9af82d07d12f3daadda and manufactured by DENKA CO., LTD. The authorized representative in Taiwan is TUNYEN ENTERPRISE CORPORATION.

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78f10d87b0b4f9af82d07d12f3daadda
Registration Details
Taiwan FDA Registration: 78f10d87b0b4f9af82d07d12f3daadda
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Device Details

Bionic Research Fast Neville Influenza and Respiratory Fusion Virus Rapid Test Kit
TW: ็”Ÿ็ ”ๅฟซ็ดๅจๆต่กŒๆ€งๆ„Ÿๅ†’่ˆ‡ๅ‘ผๅธ้“่žๅˆ็—…ๆฏ’ๅฟซ้€Ÿๆชข้ฉ—ๅฅ—็ต„
Risk Class 2

Registration Details

78f10d87b0b4f9af82d07d12f3daadda

DHA05603437304

Company Information

Japan

Product Details

This product detects influenza virus type A, B and respiratory fusion virus antigens in nasal swabs, and nasal brush solution (as an auxiliary basis for diagnosis of influenza virus or respiratory fusion virus).

C Immunology and microbiology

C.3480 Respiratory Fusion Cell Virus Serum Reagent;; C.3328 Influenza Virus Antigen Rapid Screening and Detection System;; C.2900 Instruments for the collection and delivery of microbial samples

Input;; QMS/QSD

Dates and Status

Mar 15, 2021

Mar 15, 2026