"Abbott" designer CA 19-9XR test kit - Taiwan Registration f5616ee5354c79ae8dfd5330a17247f9
Access comprehensive regulatory information for "Abbott" designer CA 19-9XR test kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f5616ee5354c79ae8dfd5330a17247f9 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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Device Details
Registration Details
f5616ee5354c79ae8dfd5330a17247f9
DHA05603114706
Product Details
The chemical cold microparticle enzyme immunoassay (CMIA) was used to quantitatively test the 1116-NS-19-9 reaction determinants in human serum or plasma on the ARCHITECT i system.
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
Input;; Contract manufacturing
Dates and Status
Jun 12, 2018
Jun 12, 2028