Taiwan FDA registration e5dffcbff44d5d2b3fd4d870ffe864a8
VIDAS High sensitive Troponin Ⅰ
TW: 威達獅高敏感度肌鈣蛋白Ⅰ試劑組
Taiwan·Risk Class 2·MD·BIOMERIEUX SA·Registered Dec 14, 2016 – Dec 14, 2026ActiveRegistration details
- Analysis ID
- e5dffcbff44d5d2b3fd4d870ffe864a8
- License Form
- Ministry of Health Medical Device Import No. 029163
- Customs Code
- DHA05602916302
Company information
- Manufacturer
- BIOMERIEUX SA
- Manufacturer Country
- France
- Authorized Representative
- Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
Product details
- Intended Use
- Vista Lion High Sensitivity Troponin I Kit is an automated quantitative test that quantifies the concentration of human plasma or serum (heparin lithium) central myotroponin I using ELFA technology (enzyme-linked fluorescence analysis) using VIDAS instruments.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1215 Creatine phosphocatalyzed?/creatine excitation or isomeric test system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 14, 2016
- Expiry Date
- Dec 14, 2026
About this record
Access comprehensive regulatory information for VIDAS High sensitive Troponin Ⅰ in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e5dffcbff44d5d2b3fd4d870ffe864a8 and manufactured by BIOMERIEUX SA. The authorized representative in Taiwan is Hong Kong Commercial Mérieux S.p.A. Taiwan Branch.
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