Taiwan FDA registration 0c37dd84595281b2c3846d04444f2aca
Beckman Coulter Total Prostate Antigen Radioimmunoassay Set
TW: 貝克曼庫爾特總攝護腺抗原放射免疫分析試劑組
Taiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered Feb 22, 2016 – Feb 22, 2026ExpiredRegistration details
- Analysis ID
- 0c37dd84595281b2c3846d04444f2aca
- Customs Code
- DHAS5602809409
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 total prostate-specific antigen in human serum was quantified in vitro by radioimmunoassay.
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- C.6010 Mass phase antigen immunoassay system;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products
- 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
- Feb 22, 2016
- Expiry Date
- Feb 22, 2026
About this record
Access comprehensive regulatory information for Beckman Coulter Total Prostate Antigen Radioimmunoassay Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0c37dd84595281b2c3846d04444f2aca 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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