The calibration solution and quality control solution of the second generation testosterone test reagent set of Abbott designer - Taiwan Registration bd17892647e89fb64695f05cde91a8f1
Access comprehensive regulatory information for The calibration solution and quality control solution of the second generation testosterone test reagent set of Abbott designer in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number bd17892647e89fb64695f05cde91a8f1 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
bd17892647e89fb64695f05cde91a8f1
DHA00602428508
Product Details
The performance has been changed to the following product, the calibration solution, for the correction of the ARCHITECT i system for the quantitative detection of testosterone in human serum and plasma. This product (QC) is used to verify the accuracy and precision of the ARCHITECT i system for the quantitative detection of testosterone in human serum and plasma.
A Clinical chemistry and clinical toxicology
A.1680 Testosterone test system
Contract manufacturing;; input
Dates and Status
Dec 05, 2012
Dec 05, 2027