Taiwan FDA registration d8a8e21392f4c409f0d3d0d1a9110d17
Vites High Sensitivity Troponin I Immunoassay Kit
TW: "維特司" 高敏感性肌鈣蛋白 I 免疫檢測試劑組
Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS·Registered Oct 22, 2024 – Oct 22, 2029ActiveRegistration details
- Analysis ID
- d8a8e21392f4c409f0d3d0d1a9110d17
- Customs Code
- DHA05603750701
Company information
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Manufacturer Country
- United Kingdom
- Authorized Representative
- DKSH TAIWAN LTD.
Product details
- Intended Use
- Quantitative determination of central troponin I (cTnI) in human serum and plasma (heparin) was performed using the Vitesus ECi/ECiQ/3600 immunodiagnostic analyzer and the Vitesus 5600/XT 7600 biochemical immunoassayer.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system; A.1150 calibration
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Oct 22, 2024
- Expiry Date
- Oct 22, 2029
About this record
Access comprehensive regulatory information for Vites High Sensitivity Troponin I Immunoassay Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d8a8e21392f4c409f0d3d0d1a9110d17 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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