Calibration solution and quality control solution of apex lipoprotein (a) test reagent group - Taiwan Registration af820341e10f0a7b91c6fb347bf58f0a
Access comprehensive regulatory information for Calibration solution and quality control solution of apex lipoprotein (a) test reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number af820341e10f0a7b91c6fb347bf58f0a and manufactured by BIOKIT S.A.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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Device Details
Product Details
Calibration Solution: This product is used to establish the calibration curve of the "Abbot" lipoprotein (a) assay set (unsterilized) on the Ainity c analyzer by turbidimetry. Pipeline Solution: This product is used as an analyzed quality management material when using turbidity method in combination with the "Apep" lipoprotein (a) assay set (unsterilized) on the Ainity c analyzer.
A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
import
Dates and Status
Feb 07, 2020
Feb 07, 2030