Taiwan FDA registration 70caa1a4d08360a3c0f4e643d290039e
Imante Newtek thyroglobulin autologous antibody test reagent
TW: 伊曼特紐特克甲狀腺球蛋白自體抗體檢驗試劑
Taiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered Jul 07, 2022 – Jul 07, 2027ActiveRegistration details
- Analysis ID
- 70caa1a4d08360a3c0f4e643d290039e
- Customs Code
- DHAS5603567201
Company information
- Manufacturer
- IMMUNOTECH S.R.O.
- Manufacturer Country
- Czechia
- Authorized Representative
- MEGA BONA INTERNATIONAL CO., LTD.
Product details
- Intended Use
- Anti-hTG autoantibodies in human serum and plasma were measured in vitro by radioimmunoassay
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5870 甲狀腺自體抗體免疫試驗系統
- Import Information
- Input;; QMS/QSD;; Consent letter must be attached to the import (consent from the Atomic Energy Commission must be obtained for each import)
Dates and status
- Registration Date
- Jul 07, 2022
- Expiry Date
- Jul 07, 2027
About this record
Access comprehensive regulatory information for Imante Newtek thyroglobulin autologous antibody test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 70caa1a4d08360a3c0f4e643d290039e and manufactured by IMMUNOTECH S.R.O.. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..
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