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Abbott CA 19-9XR assay set - Taiwan Registration ab7bf1bfa717fea06f68c51c7d7f7927

Access comprehensive regulatory information for Abbott CA 19-9XR assay set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ab7bf1bfa717fea06f68c51c7d7f7927 and manufactured by FUJIREBIO DIAGNOSTICS, INC.;; ABBOTT GmbH. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including FUJIREBIO DIAGNOSTICS, INC.;; ABBOTT GMBH, and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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ab7bf1bfa717fea06f68c51c7d7f7927
Registration Details
Taiwan FDA Registration: ab7bf1bfa717fea06f68c51c7d7f7927
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Device Details

Abbott CA 19-9XR assay set
TW: ไบžๅŸนCA 19-9XRๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

ab7bf1bfa717fea06f68c51c7d7f7927

DHA05603147306

Company Information

Product Details

This product is a chemical cold light microparticle enzyme immunoassay (CMIA) with the Alinity i analyzer to quantitatively test 1116-NS-19-9 reaction determinants in human serum or plasma.

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

Sep 19, 2018

Sep 19, 2028

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