Calibration solution and quality control solution of apex lipoprotein (a) test reagent group - Taiwan Registration 85300c78b0cb88d73ab32a826987f4f6
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 85300c78b0cb88d73ab32a826987f4f6 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 "Apepeth" lipoprotein (a) detection kit (unsterilized) on the ARCHITECT c system by turbidimetric method. Quality control solution: This product quality control solution I and quality control solution II are used as analytical quality management materials when quantitatively monitoring lipoprotein (a) by turbidimetric method with "APE" lipoprotein (a) test set (unsterilized) on the ARCHITECT c system.
A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Jan 07, 2022
Jan 07, 2027