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
Taiwan flagTaiwan·Risk Class 2·MD·Qizhe Biotechnology Co., Ltd·Registered Jan 19, 2018 – Jan 19, 2023Expired
Registration details
Analysis ID
8afb2d8656030481b8757c5acadf7083
License Form
Ministry of Health Medical Device Manufacturing No. 005814
Company information
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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