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Beckman Coulter Total Prostate Antigen Radioimmunoassay Set - Taiwan Registration 0c37dd84595281b2c3846d04444f2aca

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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0c37dd84595281b2c3846d04444f2aca
Registration Details
Taiwan FDA Registration: 0c37dd84595281b2c3846d04444f2aca
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Device Details

Beckman Coulter Total Prostate Antigen Radioimmunoassay Set
TW: ่ฒๅ…‹ๆ›ผๅบซ็ˆพ็‰น็ธฝๆ”่ญท่…บๆŠ—ๅŽŸๆ”พๅฐ„ๅ…็–ซๅˆ†ๆž่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

0c37dd84595281b2c3846d04444f2aca

DHAS5602809409

Company Information

Product Details

The content of total prostate-specific antigen in human serum was quantified in vitro by radioimmunoassay.

A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology

C.6010 Mass phase antigen immunoassay system;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products

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

Feb 22, 2016

Feb 22, 2026