Taiwan FDA registration 6f55ceae4e0d4aaf92fffb004d6b9c06

Abbott Amiciksin Test Set

TW: 亞培艾米克信檢驗試劑組
Taiwan flagTaiwan·Risk Class 2·B.R.A.H.M.S GmbH;; MICROGENICS CORPORATION·Registered Aug 02, 2019 – Aug 02, 2029Active
Registration details
Analysis ID
6f55ceae4e0d4aaf92fffb004d6b9c06
Customs Code
DHA05603247209
Company information
Manufacturer Country
United States;;Germany
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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