Taiwan FDA registration 7430f043cff3c09ea596ac1c3a9c15ae
Vida Lion Acute Kidney Injury Detection Reagent Group
TW: 威達獅急性腎損傷檢測試劑組
Registration details
- Analysis ID
- 7430f043cff3c09ea596ac1c3a9c15ae
- Customs Code
- DHA05603623604
Company information
- Manufacturer
- BIOMERIEUX SA
- Manufacturer Country
- France
- Authorized Representative
- BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG)
Product details
- Intended Use
- 本產品是一項適用於 VIDAS 3 儀器的自動化酵素免疫反應定量檢測,利用酶聯螢光分析技術 (Enzyme Linked Fluorescent Assay, ELFA) 定量檢測人類尿液中的金屬蛋白酶組織抑制因子-2(Tissue Inhibitor of Metalloproteinase-2, TIMP-2) 及類胰島素生長因子結合蛋白-7 (Insulin-like Growth Factor-Binding Protein 7, IGFBP-7).
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1220 Acute kidney injury testing system.
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Nov 23, 2023
- Expiry Date
- Nov 23, 2028
About this record
Access comprehensive regulatory information for Vida Lion Acute Kidney Injury Detection Reagent Group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7430f043cff3c09ea596ac1c3a9c15ae and manufactured by BIOMERIEUX SA. The authorized representative in Taiwan is BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG).
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