"Vstrip RV2" COVID-19 Antigen Rapid Test Home Use - Taiwan Registration b647f3fa19a70c065cceeee50693b988
Access comprehensive regulatory information for "Vstrip RV2" COVID-19 Antigen Rapid Test 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 b647f3fa19a70c065cceeee50693b988 and manufactured by Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory. The authorized representative in Taiwan is PANION & BF BIOTECH INC..
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Device Details
Registration Details
b647f3fa19a70c065cceeee50693b988
Ministry of Health Medical Device Manufacturing No. 007605
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
B4020 Analyze specific reagents
Produced in Taiwan, China; GMP
Dates and Status
Aug 24, 2023
Aug 24, 2028