Apex thyroglobulin test set - Taiwan Registration a46b58936994ab948908753062fd72d4
Access comprehensive regulatory information for Apex thyroglobulin 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 a46b58936994ab948908753062fd72d4 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
a46b58936994ab948908753062fd72d4
DHA05603439208
Product Details
This product is used to quantitatively detect thyroglobulin in human serum and plasma by chemical cold light particle immunoassay (CMIA) on the Alinity i analyzer. Testing thyroglobulin can be used to help monitor patients after a total thyroidectomy (thyroidectomy).
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
ๅง่จ่ฃฝ้ ;; QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Apr 14, 2021
Apr 14, 2026

