"Filco RV2" Novel Coronavirus Antigen Rapid Test Reagent for Home Use
Taiwan·Risk Class 3·Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory·Registered Aug 24, 2023 – Aug 24, 2028Active- Analysis ID
- e27cce2dfd6f75b3cb1c5144063f7e02
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory
- Intended Use
- 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.
- 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
- Registration Date
- Aug 24, 2023
- Expiry Date
- Aug 24, 2028
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.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.