Taiwan FDA registration e37cf813833ba0de1230462e27370a05
CJ EZ Drop CA 125 Test
TW: 啟哲易滴醣質化抗原125體外試劑組
Taiwan·Risk Class 2·MD·Qizhe Biotechnology Co., Ltd·Registered Apr 30, 2018 – Apr 30, 2023ExpiredRegistration details
- Analysis ID
- e37cf813833ba0de1230462e27370a05
- License Form
- Ministry of Health Medical Device Manufacturing No. 005823
Company information
- Manufacturer
- Qizhe Biotechnology Co., Ltd
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Qizhe Biotechnology Co., Ltd
Product details
- Intended Use
- This product is equipped with Qizhe color analyzer (Weibu Medical Instrument No. 007660), which can quantitatively detect the concentration of glycogenic antigen 125 (CA 125) in human serum.
- 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
- Apr 30, 2018
- Expiry Date
- Apr 30, 2023
About this record
Access comprehensive regulatory information for CJ EZ Drop CA 125 Test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e37cf813833ba0de1230462e27370a05 and manufactured by Qizhe Biotechnology Co., Ltd. The authorized representative in Taiwan is Qizhe Biotechnology Co., Ltd.
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