Apex neuron-specific enolase assay set - Taiwan Registration be663be8cbc1304289b9c7bceb6c0950
Access comprehensive regulatory information for Apex neuron-specific enolase assay set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number be663be8cbc1304289b9c7bceb6c0950 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
be663be8cbc1304289b9c7bceb6c0950
DHA05603522609
Product Details
This product is used to quantify neuron-specific enolase (NSE) in human serum by chemical cold light particle immunoassay (CMIA) on the Alinity 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
ๅง่จ่ฃฝ้ ;; QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Mar 11, 2022
Mar 11, 2027

