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.
Device Details
Registration Details
a418a72e05fac735e864829d1763d0d3
DHA05603330001
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

