Abbott Designer CA 125 II Test Kit - Taiwan Registration 86550b4a57803fffc12aa870e8180891
Access comprehensive regulatory information for Abbott Designer CA 125 II 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 86550b4a57803fffc12aa870e8180891 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
86550b4a57803fffc12aa870e8180891
DHA00601303003
Product Details
This product is used for the quantitative detection of OC 125 defined antigen in human serum and plasma by chemical cold light particle immunoassay (CMIA) on the ARCHITECT i system. This product is used to assist in monitoring the response to treatment in patients with epithelial ovarian cancer. Consecutive patient CA 125 II analysis values should be used in conjunction with other clinical methods for monitoring ovarian cancer.
C Immunology and microbiology
import
Dates and Status
Sep 23, 2005
Sep 23, 2025