Taiwan FDA registration dd485cd6dc24fa4f54469692125e1922

Apevancomycin test set

TW: 亞培萬古黴素檢驗試劑組

Taiwan·Risk Class 2·B.R.A.H.M.S GmbH;; MICROGENICS CORPORATION·Registered Oct 31, 2019 – Oct 31, 2029Active

Registration details

Analysis ID: dd485cd6dc24fa4f54469692125e1922
Customs Code: DHA05603295605

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 quantitatively tested for vancomycin in human serum or plasma on an Alinity c analyzer.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.39.5 million vancomycin test system
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Oct 31, 2019
Expiry Date: Oct 31, 2029

About this record

Access comprehensive regulatory information for Apevancomycin 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 dd485cd6dc24fa4f54469692125e1922 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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