Abbott CA 15-3 Test Set - Taiwan Registration 6f7f49945c8453538d0a249c61a1e80f
Access comprehensive regulatory information for Abbott CA 15-3 Test Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6f7f49945c8453538d0a249c61a1e80f 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
6f7f49945c8453538d0a249c61a1e80f
DHA05603114808
Product Details
The change to efficacy (adjusted textual description) is as follows: This product is used for the quantitative detection of DF3 defined antigen in human serum and 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
Contract manufacturing;; input
Dates and Status
Jun 11, 2018
Jun 11, 2028