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Abbott designer neuron-specific enolase assay set - Taiwan Registration a418a72e05fac735e864829d1763d0d3

Access comprehensive regulatory information for Abbott designer 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 a418a72e05fac735e864829d1763d0d3 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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a418a72e05fac735e864829d1763d0d3
Registration Details
Taiwan FDA Registration: a418a72e05fac735e864829d1763d0d3
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Device Details

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

Registration Details

a418a72e05fac735e864829d1763d0d3

DHA05603330001

Company Information

Product Details

This product is used to quantitatively detect neuronspecific enolase in human serum by chemical cold light particle immunoassay (CMIA) on the ARCHITECT i system; NSE).

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

Input;; Contract manufacturing

Dates and Status

Mar 27, 2020

Mar 27, 2030