Taiwan FDA registration 256fb76d9fc9775af53c4fafdb841080
麳麞奇antigen CA19-9 Radioimmunoassay Panel
TW: 鐳亞奇抗原 CA19-9 放射免疫分析試劑組
Taiwan·Risk Class 2·Shin Jin Medics Inc.·Registered Jan 12, 2024 – Jan 12, 2029ActiveRegistration details
- Analysis ID
- 256fb76d9fc9775af53c4fafdb841080
- Customs Code
- DHAS5603705207
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 a quantitative measure of glycocate antigen CA19-9 in human serum using 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
- Input;; Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); QMS/QSD
Dates and status
- Registration Date
- Jan 12, 2024
- Expiry Date
- Jan 12, 2029
About this record
Access comprehensive regulatory information for 麳麞奇antigen CA19-9 Radioimmunoassay Panel in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 256fb76d9fc9775af53c4fafdb841080 and manufactured by Shin Jin Medics Inc.. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..
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