Taiwan FDA registration fd10fe86d8e608917004236b532bf745

Apexylline assay group

TW: 亞培茶鹼檢驗試劑組

Taiwan·Risk Class 2·B.R.A.H.M.S GmbH;; MICROGENICS CORPORATION·Registered Sep 10, 2019 – Sep 10, 2029Active

Registration details

Analysis ID: fd10fe86d8e608917004236b532bf745
Customs Code: DHA05603249508

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 measurement of theophylline 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.3880 茶鹼試驗系統
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Sep 10, 2019
Expiry Date: Sep 10, 2029

About this record

Access comprehensive regulatory information for Apexylline assay group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fd10fe86d8e608917004236b532bf745 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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