Taiwan FDA registration fc9294784c1380e923fc75d6382a48db
生物梅里埃易特試梯度條抗生素感受性檢測 – Imipenem/Relebactam
Taiwan·Risk Class 2·BIOMERIEUX SA·Registered Jan 24, 2024 – Jan 24, 2029ActiveRegistration details
- Analysis ID
- fc9294784c1380e923fc75d6382a48db
- Customs Code
- DHA05603705607
Company information
- Manufacturer
- BIOMERIEUX SA
- Manufacturer Country
- France
- Authorized Representative
- BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG)
Product details
- Intended Use
- 本產品為抗生素感受性的手工定量檢測技術,可用於測定 Citrobacter freundii、Enterobacter cloacae/ Enterobacter cloacae complex、Escherichia coli、Klebsiella aerogenes、Klebsiella oxytoca 及 Klebsiella pneumoniae 對於 Imipenem/Relebactam 的最低抑菌濃度 (Minimum Inhibitory Concentration, MIC),單位以μg/mL 表示.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.1640 抗菌感受性試驗粉末
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jan 24, 2024
- Expiry Date
- Jan 24, 2029
About this record
Access comprehensive regulatory information for 生物梅里埃易特試梯度條抗生素感受性檢測 – Imipenem/Relebactam in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fc9294784c1380e923fc75d6382a48db and manufactured by BIOMERIEUX SA. The authorized representative in Taiwan is BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG).
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