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
Taiwan flagTaiwan·Risk Class 2·BIOMERIEUX SA·Registered Nov 23, 2023 – Nov 23, 2028Active
Registration details
Analysis ID
7430f043cff3c09ea596ac1c3a9c15ae
Customs Code
DHA05603623604
Company information
Manufacturer
BIOMERIEUX SA
Manufacturer Country
France
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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