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Calibration solution and quality control solution of Abbott clinical biochemical microalbumin test group - Taiwan Registration 68f1419c3786d5b8d4745eedf1d833bb

Access comprehensive regulatory information for Calibration solution and quality control solution of Abbott clinical biochemical microalbumin test group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 68f1419c3786d5b8d4745eedf1d833bb and manufactured by ABBOTT IRELAND DIAGNOSTICS DIVISION;; ABBOTT GMBH. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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68f1419c3786d5b8d4745eedf1d833bb
Registration Details
Taiwan FDA Registration: 68f1419c3786d5b8d4745eedf1d833bb
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Device Details

Calibration solution and quality control solution of Abbott clinical biochemical microalbumin test group
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Risk Class 2

Registration Details

68f1419c3786d5b8d4745eedf1d833bb

DHA05603588701

Company Information

Product Details

Calibration solution: Used on the ARCHITECT c system to correct the "Apepto" microalbumin test set (unsterilized). Quality control solution: used on the ARCHITECT c system, quality management "APE" microalbumin test set (unsterilized).

A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration

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Dates and Status

Dec 01, 2022

Dec 01, 2027