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"Tecno" high-sensitivity troponin I quality tube solution - Taiwan Registration 9aeb9c5680652d252329b2af91338e50

Access comprehensive regulatory information for "Tecno" high-sensitivity troponin I quality tube solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9aeb9c5680652d252329b2af91338e50 and manufactured by TECHNO-PATH MANUFACTURING LTD. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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9aeb9c5680652d252329b2af91338e50
Registration Details
Taiwan FDA Registration: 9aeb9c5680652d252329b2af91338e50
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Device Details

"Tecno" high-sensitivity troponin I quality tube solution
TW: "ๆณฐๅฏ่ซพ"้ซ˜้ˆๆ•ๅบฆ่‚Œ้ˆฃ่›‹็™ฝIๅ“็ฎกๆถฒ
Risk Class 2

Registration Details

9aeb9c5680652d252329b2af91338e50

DHA05603490501

Company Information

Product Details

This product can be used as a single concentration analyzed mass management material to monitor precision when using high-sensitivity troponin analysis on automated analyzers for the detection of troponin I, the analyte listed in this specification.

A Clinical chemistry and clinical toxicology

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

Input;; QMS/QSD

Dates and Status

Sep 09, 2021

Sep 09, 2026