Taiwan FDA registration 566f87e06fe872e65363e6f11738ef33
Formosa One Sure Flu A/B Rapid Test kit
TW: 台塑生醫迅知A/B型流行性感冒病毒快速檢驗試劑
Taiwan·Risk Class 2·MD·Formosa Biomedical Technology Co., Ltd. Yilan Factory·Registered Jun 29, 2020 – Jun 29, 2025ExpiredRegistration details
- Analysis ID
- 566f87e06fe872e65363e6f11738ef33
- License Form
- Ministry of Health Medical Device Manufacturing No. 006720
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION
Product details
- Intended Use
- This product is used by immunoassay chromatography to qualitatively detect influenza A and/or B influenza virus antigens in human nasal or throat secretions, which can be used for preliminary screening.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3328 Influenza Virus Antigen Rapid Screening System
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Jun 29, 2020
- Expiry Date
- Jun 29, 2025
About this record
Access comprehensive regulatory information for Formosa One Sure Flu A/B Rapid Test kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 566f87e06fe872e65363e6f11738ef33 and manufactured by Formosa Biomedical Technology Co., Ltd. Yilan Factory. The authorized representative in Taiwan is FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION.
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