Abbott Designer CA 19-9XR Test Kit - Taiwan Registration 3a0e9924bdda0623ced86f36b9e3ce04
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 3a0e9924bdda0623ced86f36b9e3ce04 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
3a0e9924bdda0623ced86f36b9e3ce04
DHA05603624801
Product Details
This product is used for the quantitative detection of 1116-NS-19-9 reaction determinants in human serum or plasma by chemically cold light particle immunoassay (CMIA) 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
่ผธๅ ฅ;; QMS/QSD;; ๅง่จ่ฃฝ้
Dates and Status
Dec 27, 2023
Dec 27, 2028

