Taiwan FDA registration fbe600685e3e5dfc52e2a0f659f2ae06
Emanutec CA125 antigen radioimmunoassay reagent group
TW: 伊曼紐特克CA125抗原放射免疫分析試劑組
Taiwan·Risk Class 2·IMMUNOTECH S.R.O·Registered Mar 17, 2021 – Mar 17, 2026ExpiredRegistration details
- Analysis ID
- fbe600685e3e5dfc52e2a0f659f2ae06
- Customs Code
- DHA05603437406
Company information
- Manufacturer
- IMMUNOTECH S.R.O
- Manufacturer Country
- Czechia
- Authorized Representative
- MEGA BONA INTERNATIONAL CO., LTD.
Product details
- Intended Use
- Determination of CA125 antigen in human serum and plasma by external beam immunoassay.
- 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
- QMS/QSD;; Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); input
Dates and status
- Registration Date
- Mar 17, 2021
- Expiry Date
- Mar 17, 2026
About this record
Access comprehensive regulatory information for Emanutec CA125 antigen radioimmunoassay reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fbe600685e3e5dfc52e2a0f659f2ae06 and manufactured by IMMUNOTECH S.R.O. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..
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