"Filco RV2" Novel Coronavirus Antigen Rapid Test Reagent for Home Use - Taiwan Registration e27cce2dfd6f75b3cb1c5144063f7e02
Access comprehensive regulatory information for "Filco RV2" Novel Coronavirus Antigen Rapid Test Reagent for Home Use in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number e27cce2dfd6f75b3cb1c5144063f7e02 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 detect the presence of SARS-CoV-2 in the nasal cavity of patients with suspected COVID-19 in a rapid and qualitative manner. A positive result does not rule out bacterial or other viral co-infection. A negative result does not completely rule out the possibility of novel coronavirus infection. The test results of this product should not be used as the sole basis for patient management.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
QMS/QSD;; ๅ็ข
Dates and Status
Aug 24, 2023
Aug 24, 2028