Taiwan FDA registration 3170f438f2279c8ede0394743fc328f1

Api ethanol assay set

TW: 亞培乙醇檢驗試劑組

Taiwan·Risk Class 2·B.R.A.H.M.S GmbH;; MICROGENICS CORPORATION·Registered Dec 18, 2020 – Dec 18, 2025Expired

Registration details

Analysis ID: 3170f438f2279c8ede0394743fc328f1
Customs Code: DHA05603417704

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 detection of ethanol in human urine, serum or plasma on an Alinity c analyzer.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products;; A.3040 Sake Essence Trial System
Import Information: QMS/QSD;; 委託製造;; 輸入

Dates and status

Registration Date: Dec 18, 2020
Expiry Date: Dec 18, 2025

About this record

Access comprehensive regulatory information for Api ethanol assay set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3170f438f2279c8ede0394743fc328f1 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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