Taiwan FDA registration ad22ea9754c1d1eebcb11921926a58b6
Beckman Coulter β-2 microglobulin radioimmunoassay group
TW: 貝克曼庫爾特β-2微球蛋白放射免疫分析試劑組
Taiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered Mar 03, 2016 – Mar 03, 2026ExpiredRegistration details
- Analysis ID
- ad22ea9754c1d1eebcb11921926a58b6
- Customs Code
- DHAS5602811007
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
- In vitro diagnostic of human serum, plasma, and urine levels of β-2 microglobulins using radioimmunoassays.
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- A.1660 品管材料(分析與非分析);; A.1150 校正品;; C.5630 β-2-微球蛋白免疫試驗系統
- Import Information
- Input;; 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
- Mar 03, 2016
- Expiry Date
- Mar 03, 2026
About this record
Access comprehensive regulatory information for Beckman Coulter β-2 microglobulin radioimmunoassay group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ad22ea9754c1d1eebcb11921926a58b6 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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