Taiwan FDA registration b647f3fa19a70c065cceeee50693b988

"Vstrip RV2" COVID-19 Antigen Rapid Test Home Use

TW: "飛確 RV2" 家用新型冠狀病毒抗原快速檢驗試劑

Taiwan·Risk Class 3·MD·Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory·Registered Aug 24, 2023 – Aug 24, 2028Active

Registration details

Analysis ID: b647f3fa19a70c065cceeee50693b988
License Form: Ministry of Health Medical Device Manufacturing No. 007605

Company information

Manufacturer: Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: PANION & BF BIOTECH INC.

Product details

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): B4020 Analyze specific reagents
Import Information: Produced in Taiwan, China; GMP

Dates and status

Registration Date: Aug 24, 2023
Expiry Date: Aug 24, 2028

About this record

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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