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Calibration solution and quality control solution of Abbott microalbumin test reagent group - Taiwan Registration ff3500122db59d7a20d02bede5bd885a

Access comprehensive regulatory information for Calibration solution and quality control solution of Abbott microalbumin 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 ff3500122db59d7a20d02bede5bd885a 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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ff3500122db59d7a20d02bede5bd885a
Registration Details
Taiwan FDA Registration: ff3500122db59d7a20d02bede5bd885a
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Device Details

Calibration solution and quality control solution of Abbott microalbumin test reagent group
TW: ไบžๅŸนๅพฎ็™ฝ่›‹็™ฝๆชข้ฉ—่ฉฆๅŠ‘็ต„ไน‹ๆ กๆญฃๆถฒๅŠๅ“็ฎกๆถฒ
Risk Class 2

Registration Details

ff3500122db59d7a20d02bede5bd885a

DHA05603523102

Company Information

Product Details

Calibration solution: Used to correct the "Abbot" microalbumin test set on the Alinity c system. Quality control solution: used in the Alinity c system, quality management "Apez" microalbumin test kit.

A Clinical chemistry and clinical toxicology

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

ๅง”่จ—่ฃฝ้€ ;; QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Mar 25, 2022

Mar 25, 2027