Taiwan FDA registration 9aeb9c5680652d252329b2af91338e50
"Tecno" high-sensitivity troponin I quality tube solution
TW: "泰可諾"高靈敏度肌鈣蛋白I品管液
Taiwan·Risk Class 2·TECHNO-PATH MANUFACTURING LTD·Registered Sep 09, 2021 – Sep 09, 2026ActiveRegistration details
- Analysis ID
- 9aeb9c5680652d252329b2af91338e50
- Customs Code
- DHA05603490501
Company information
- Manufacturer
- TECHNO-PATH MANUFACTURING LTD
- Manufacturer Country
- Ireland
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Sep 09, 2021
- Expiry Date
- Sep 09, 2026
About this record
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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