Taiwan FDA registration 4aeb8e8ea3e0605cc9feb3ca0fb578ed
"Siemens" High Sensitivity Cardiac Troponin I Test Kit
TW: "西門子" 高靈敏度心肌肌鈣蛋白 I 檢驗試劑盒
Taiwan·Risk Class 2·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Registered Oct 05, 2023 – Oct 05, 2028ActiveRegistration details
- Analysis ID
- 4aeb8e8ea3e0605cc9feb3ca0fb578ed
- Customs Code
- DHA05603622805
Company information
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Manufacturer Country
- United States
- Authorized Representative
- SIEMENS HEALTHCARE LIMITED
Product details
- Intended Use
- This product is intended for in vitro diagnostic use for the quantitative determination of cardiac troponin I (cTnI) in human microvascular (finger prick) whole blood and lithium heparin, venous whole blood or plasma in combination with the Atellica VTLi Immunoassay Analyzer.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Oct 05, 2023
- Expiry Date
- Oct 05, 2028
About this record
Access comprehensive regulatory information for "Siemens" High Sensitivity Cardiac Troponin I Test Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4aeb8e8ea3e0605cc9feb3ca0fb578ed and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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