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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.).

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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be663be8cbc1304289b9c7bceb6c0950
Registration Details
Taiwan FDA Registration: be663be8cbc1304289b9c7bceb6c0950
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Device Details

Apex neuron-specific enolase assay set
TW: ไบžๅŸน็ฅž็ถ“ๅ…ƒ็‰น็•ฐๆ€ง็ƒฏ้†‡้…ถๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

be663be8cbc1304289b9c7bceb6c0950

DHA05603522609

Company Information

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

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Dates and Status

Mar 11, 2022

Mar 11, 2027