Fido RV2 Novel Coronavirus Antigen Rapid Test Reagent - Taiwan Registration 291fe6699a227cb880bfe04bc68cf501
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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Device Details
Product Details
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.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
QMS/QSD;; ๅ็ข
Dates and Status
Jun 13, 2023
Jun 13, 2028