Taiwan FDA registration 8afb2d8656030481b8757c5acadf7083
CJ Rapitest AFP test kit
TW: 啟哲速測家甲型胎兒蛋白檢測試劑組
Registration details
- Analysis ID
- 8afb2d8656030481b8757c5acadf7083
- License Form
- Ministry of Health Medical Device Manufacturing No. 005814
Company information
- Manufacturer
- Qizhe Biotechnology Co., Ltd
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Qizhe Biotechnology Co., Ltd
Product details
- Intended Use
- Qualitative detection of human serum α-Fetoprotein (AFP).
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C6010 Tumor-associated antigen immunoassay system
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Jan 19, 2018
- Expiry Date
- Jan 19, 2023
About this record
Access comprehensive regulatory information for CJ Rapitest AFP 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 8afb2d8656030481b8757c5acadf7083 and manufactured by Qizhe Biotechnology Co., Ltd. The authorized representative in Taiwan is Qizhe Biotechnology Co., Ltd.
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