Taiwan FDA registration 897600a63777abb7bbadec2a0bb3aa58
Emanutek thyroglobulin radioimmunoassay reagent
TW: 伊曼紐特克甲狀腺球蛋白放射免疫分析試劑
Taiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered Jan 25, 2022 – Jan 25, 2027ActiveRegistration details
- Analysis ID
- 897600a63777abb7bbadec2a0bb3aa58
- Customs Code
- DHA05603521201
Company information
- Manufacturer
- IMMUNOTECH S.R.O.
- Manufacturer Country
- Czechia
- Authorized Representative
- MEGA BONA INTERNATIONAL CO., LTD.
Product details
- Intended Use
- External immunoradiation assays for thyroglobulin (Tg) in human serum and plasma for in vitro diagnostic use.
- 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 25, 2022
- Expiry Date
- Jan 25, 2027
About this record
Access comprehensive regulatory information for Emanutek thyroglobulin radioimmunoassay reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 897600a63777abb7bbadec2a0bb3aa58 and manufactured by IMMUNOTECH S.R.O.. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..
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