Taiwan FDA registration 78f10d87b0b4f9af82d07d12f3daadda

Bionic Research Fast Neville Influenza and Respiratory Fusion Virus Rapid Test Kit

TW: 生研快納威流行性感冒與呼吸道融合病毒快速檢驗套組

Taiwan·Risk Class 2·DENKA CO., LTD·Registered Mar 15, 2021 – Mar 15, 2026Expired

Registration details

Analysis ID: 78f10d87b0b4f9af82d07d12f3daadda
Customs Code: DHA05603437304

Company information

Manufacturer: DENKA CO., LTD
Manufacturer Country: Japan
Authorized Representative: TUNYEN ENTERPRISE CORPORATION

Product details

Intended Use: 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).
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): 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
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Mar 15, 2021
Expiry Date: Mar 15, 2026

About this record

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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