Taiwan FDA registration e05de0393fbcfdc693587a36db367835

"Abbott" TDM complex correction solution

TW: “亞培”TDM 複合校正液
Taiwan flagTaiwan·Risk Class 2·B.R.A.H.M.S GmbH;; MICROGENICS CORPORATION·Registered Apr 15, 2019 – Apr 15, 2029Active
Registration details
Analysis ID
e05de0393fbcfdc693587a36db367835
Customs Code
DHA05603240609
Company information
Manufacturer Country
United States;;Germany
Product details
Intended Use
This product is suitable for in vitro diagnostics, with Alinity c system for the detection of digheroid, gentamicin, diphenyllactamuria and vancomycin in human serum or plasma. This product (specification: 08P7403) is suitable for in vitro diagnostics, with the Alinity c system for the calibration and detection of Amikacin, foxglove, Gentamicin, phenylbarbital, diphenyllactium, Theophylline, and Valproic Acid) and Vancomycin for analysis.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1150 Calibrated Products
Import Information
Input;; Contract manufacturing
Dates and status
Registration Date
Apr 15, 2019
Expiry Date
Apr 15, 2029
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About this record

Access comprehensive regulatory information for "Abbott" TDM complex correction solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e05de0393fbcfdc693587a36db367835 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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