Taiwan FDA registration 6df10ff245c52fe1c075a26a08ae282b
Beckman Coulter estrone radioimmunoassay reagent
TW: 貝克曼庫爾特雌素酮放射免疫分析試劑
Taiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered Jan 14, 2016 – Jan 14, 2026ExpiredRegistration details
- Analysis ID
- 6df10ff245c52fe1c075a26a08ae282b
- Customs Code
- DHAS5602807100
Company information
- Manufacturer
- IMMUNOTECH S.R.O.
- Manufacturer Country
- Czechia
- Authorized Representative
- BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- The content of estrone in human serum and plasma was quantitatively detected in vitro by radioimmunoassay.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products;; A.1280 Female Element Trial Lines
- Import Information
- 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
- Jan 14, 2016
- Expiry Date
- Jan 14, 2026
About this record
Access comprehensive regulatory information for Beckman Coulter estrone 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 6df10ff245c52fe1c075a26a08ae282b and manufactured by IMMUNOTECH S.R.O.. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).
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