Taiwan FDA registration 6f55ceae4e0d4aaf92fffb004d6b9c06
Abbott Amiciksin Test Set
TW: 亞培艾米克信檢驗試劑組
Registration details
- Analysis ID
- 6f55ceae4e0d4aaf92fffb004d6b9c06
- Customs Code
- DHA05603247209
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 determination of amikacin in human serum or plasma on an Alinity c analyzer. The measurements obtained can be used to diagnose and treat an amiksin overdose, as well as to monitor the concentration of amiksin to ensure appropriate treatment.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.3035 Amicon mycin (drug name) test system
- Import Information
- Input;; Contract manufacturing
Dates and status
- Registration Date
- Aug 02, 2019
- Expiry Date
- Aug 02, 2029
About this record
Access comprehensive regulatory information for Abbott Amiciksin Test Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6f55ceae4e0d4aaf92fffb004d6b9c06 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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