Taiwan FDA registration 77b8e1989c8fbc8d77b5ebcb895a0ef8
VIDAS D-Dimer Exclusion II (DEX 2)
TW: 威達獅 D-二聚體第二代試劑組
Taiwan·Risk Class 2·MD·BIOMERIEUX SA·Registered Sep 04, 2018 – Sep 04, 2028ActiveRegistration details
- Analysis ID
- 77b8e1989c8fbc8d77b5ebcb895a0ef8
- License Form
- Ministry of Health Medical Device Import No. 031452
- Customs Code
- DHA05603145201
Company information
- Manufacturer
- BIOMERIEUX SA
- Manufacturer Country
- France
- Authorized Representative
- Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
Product details
- Intended Use
- This product is an automated quantitative assay with VIDAS instrument with ELFA technology (enzyme-linked fluorescence analysis) to quantitatively determine fibrin degradation products (FbDP) in human plasma (sodium citrate).
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B7320 Fibrinogen Fibrinogen Breakdown Product Analysis
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 04, 2018
- Expiry Date
- Sep 04, 2028
About this record
Access comprehensive regulatory information for VIDAS D-Dimer Exclusion II (DEX 2) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 77b8e1989c8fbc8d77b5ebcb895a0ef8 and manufactured by BIOMERIEUX SA. The authorized representative in Taiwan is Hong Kong Commercial Mérieux S.p.A. Taiwan Branch.
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