Taiwan FDA registration 109873bae71aea9c7a1dcb0d2b8f4ae3
Apeggentamicin test panel
TW: 亞培慶大黴素檢驗試劑組
Taiwan·Risk Class 2·B.R.A.H.M.S GmbH;; MICROGENICS CORPORATION·Registered Jan 12, 2022 – Jan 12, 2027ActiveRegistration details
- Analysis ID
- 109873bae71aea9c7a1dcb0d2b8f4ae3
- Customs Code
- DHA05603520300
Company information
- Manufacturer
- B.R.A.H.M.S GmbH;; MICROGENICS CORPORATION
- Manufacturer Country
- United States;;Germany
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product is used for the quantitative detection of gentamicin in human serum or plasma on the Alinity c analyzer.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.3450 Gentamicin Test System
- Import Information
- 輸入;; QMS/QSD;; 委託製造
Dates and status
- Registration Date
- Jan 12, 2022
- Expiry Date
- Jan 12, 2027
About this record
Access comprehensive regulatory information for Apeggentamicin test panel in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 109873bae71aea9c7a1dcb0d2b8f4ae3 and manufactured by B.R.A.H.M.S GmbH;; MICROGENICS CORPORATION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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