Apex homocysteine assay group - Taiwan Registration 1fa40a0fb276b6701ba631cba63d8315
Access comprehensive regulatory information for Apex homocysteine assay group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1fa40a0fb276b6701ba631cba63d8315 and manufactured by Axis-Shield Diagnostics Limited;; 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
1fa40a0fb276b6701ba631cba63d8315
DHA05603217108
Product Details
This product is used on the Alinity i analyzer for the quantitative determination of total L-homocysteine in human serum or plasma by chemiluminescent microparticle immunoassay (CMIA).
A Clinical chemistry and clinical toxicology
A.1377 Urinary bladder acid, non-quantitative test system;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products
import
Dates and Status
Feb 13, 2019
Feb 13, 2029