Taiwan FDA registration 0ffb32dfcad7d968718afe33f011fbaf

Abbott diphenytoin test group

TW: 亞培二苯妥因檢驗試劑組

Taiwan·Risk Class 2·B.R.A.H.M.S GmbH;; MICROGENICS CORPORATION·Registered Sep 20, 2019 – Sep 20, 2029Active

Registration details

Analysis ID: 0ffb32dfcad7d968718afe33f011fbaf
Customs Code: DHA05603292405

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 on the Alinity c analyzer to quantitatively measure diphenytoin in human serum or plasma for in vitro diagnostics.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.3350 Diphenyllacturic acid urine test system
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Sep 20, 2019
Expiry Date: Sep 20, 2029

About this record

Access comprehensive regulatory information for Abbott diphenytoin test group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0ffb32dfcad7d968718afe33f011fbaf 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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