Taiwan FDA registration 8cc0810c046cd546f8fe431a49767a20
Electroimmunoassay test group for fetal protein type A
TW: 鐳亞奇甲型胎兒蛋白放射免疫分析試劑組
Taiwan·Risk Class 2·Shin Jin Medics Inc.·Registered May 16, 2024 – May 16, 2029ActiveRegistration details
- Analysis ID
- 8cc0810c046cd546f8fe431a49767a20
- Customs Code
- DHAS5603707700
Company information
- Manufacturer
- Shin Jin Medics Inc.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- MEGA BONA INTERNATIONAL CO., LTD.
Product details
- Intended Use
- This product is the quantitative determination of alpha-fetal protein in human serum by in vitro radioimmunoassay.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.6010 腫瘤相關抗原免疫試驗系統
- Import Information
- The consent of the Nuclear Safety Commission must be obtained for each import of this medical device.;; Input;; QMS/QSD
Dates and status
- Registration Date
- May 16, 2024
- Expiry Date
- May 16, 2029
About this record
Access comprehensive regulatory information for Electroimmunoassay test group for fetal protein type A in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8cc0810c046cd546f8fe431a49767a20 and manufactured by Shin Jin Medics Inc.. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..
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