Taiwan FDA registration 291fe6699a227cb880bfe04bc68cf501

Fido RV2 Novel Coronavirus Antigen Rapid Test Reagent

TW: 飛確 RV2新型冠狀病毒抗原快速檢驗試劑
Taiwan flagTaiwan·Risk Class 3·Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory·Registered Jun 13, 2023 – Jun 13, 2028Active
Registration details
Analysis ID
291fe6699a227cb880bfe04bc68cf501
Company information
Manufacturer Country
Taiwan, Province of China
Product details
Intended Use
The purpose of this product is to quickly and qualitatively detect whether the nasal cavity and nasopharyngeal swab specimens of patients suspected of infection with novel coronavirus pneumonia (COVID-19) within 5 days of the appearance of suspected symptoms of novel coronavirus pneumonia (COVID-19) have novel coronavirus (SARS-CoV-2). The novel coronavirus (SARS-CoV-2) is commonly present in upper respiratory tract specimens during the acute phase of infection. A positive result indicates the presence of viral antigens in the specimen, but does not rule out co-infection with bacteria or other viruses. Clinically, the correlation of the patient's history with other diagnostic information also needs to be considered in parallel to assess the status of infection; a negative result does not completely exclude the possibility of coronavirus infection, and molecular diagnosis (PCR) can be performed if necessary. This product is intended for professional use only.
Product Type (Level 1)
B Hematology, pathology, and genetics
Product Type (Level 2)
B.4020 Analysis of specific tests
Import Information
QMS/QSD;; 國產
Dates and status
Registration Date
Jun 13, 2023
Expiry Date
Jun 13, 2028
About this record

Access comprehensive regulatory information for Fido RV2 Novel Coronavirus Antigen Rapid Test Reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 291fe6699a227cb880bfe04bc68cf501 and manufactured by Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory. The authorized representative in Taiwan is Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory.

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