Abbott CA 19-9XR Assay Set - Taiwan Registration aff5887f8a940d45768d5da4d2ed3879
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 aff5887f8a940d45768d5da4d2ed3879 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.
Device Details
Registration Details
aff5887f8a940d45768d5da4d2ed3879
DHA05603624301
Product Details
This product is intended for the quantitative detection of 1116-NS-19-9 reaction determinants in human serum or plasma by chemical cold light particle immunoassay (CMIA) on the Alinity i analyzer.
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
QMS/QSD;; ่ผธๅ ฅ;; ๅง่จ่ฃฝ้
Dates and Status
Dec 18, 2023
Dec 18, 2028