Taiwan FDA registration 31d42ae35468594c9b4dc85f64bed5ce
CJ EZ Drop PSA Test
TW: 啟哲易滴前列腺特異性抗原體外試劑組
Taiwan·Risk Class 2·MD·Qizhe Biotechnology Co., Ltd·Registered Apr 21, 2017 – Apr 21, 2022ExpiredRegistration details
- Analysis ID
- 31d42ae35468594c9b4dc85f64bed5ce
- License Form
- Ministry of Health Medical Device Manufacturing No. 005604
Company information
- Manufacturer
- Qizhe Biotechnology Co., Ltd
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Qizhe Biotechnology Co., Ltd
Product details
- Intended Use
- Performance change: This product is used with Qizhe Color Analyzer (Weibu Medical Instrument No. 007660), which can quantitatively detect the concentration of prostate-specific antigen (PSA) 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 21, 2017
- Expiry Date
- Apr 21, 2022
About this record
Access comprehensive regulatory information for CJ EZ Drop PSA Test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 31d42ae35468594c9b4dc85f64bed5ce and manufactured by Qizhe Biotechnology Co., Ltd. The authorized representative in Taiwan is Qizhe Biotechnology Co., Ltd.
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