Calibration solution and quality control solution of Abbott second-generation testosterone test reagent group - Taiwan Registration b9f5095afd75343b739255ba5955e9b8
Access comprehensive regulatory information for Calibration solution and quality control solution of Abbott second-generation testosterone 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 b9f5095afd75343b739255ba5955e9b8 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
b9f5095afd75343b739255ba5955e9b8
DHA05603133800
Product Details
07P6801 performance changed to: This product is used for the quantitative detection of testosterone in human serum and plasma, calibrating the Alinity i analyzer. 07P6810 performance changed to: This product is used to quantitatively detect testosterone in human serum and plasma to verify the accuracy and precision of the Alinity i analyzer.
A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
import
Dates and Status
Jul 30, 2018
Jul 30, 2028