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Abbott CA125II assay group - Taiwan Registration ff2535f452fc7e349d6eeece989921ad

Access comprehensive regulatory information for Abbott CA125II assay group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ff2535f452fc7e349d6eeece989921ad and manufactured by FUJIREBIO DIAGNOSTICS, INC.;; ABBOTT GmbH. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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ff2535f452fc7e349d6eeece989921ad
Registration Details
Taiwan FDA Registration: ff2535f452fc7e349d6eeece989921ad
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Device Details

Abbott CA125II assay group
TW: ไบžๅŸนCA125IIๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

ff2535f452fc7e349d6eeece989921ad

DHA05603113601

Company Information

Product Details

ๆœฌ็”ขๅ“็”จๆ–ผAlinity i ๅˆ†ๆžๅ„€ไธŠ,ไปฅๅŒ–ๅญธๅ†ทๅ…‰ๅพฎ็ฒ’็š„immunoๅˆ†ๆžๆณ• (chemiluminescent microparticle immunoassay; CMIA) Quantitative Measurements Human Serum and Plasma Oil OC 125 Defined Antigen (OC 125 defined antigen).

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

Contract manufacturing;; input

Dates and Status

Jun 04, 2018

Jun 04, 2028