Taiwan FDA registration 3e0c851dcdc7ebcf1092e0c15a1d2e22
Abbec direct bilirubin test set
TW: 亞培直接膽紅素檢驗試劑組
Taiwan·Risk Class 2·ABBOTT GMBH;; SEKISUI DIAGNOSTICS P.E.I. INC.·Registered Jan 25, 2019 – Jan 25, 2029ActiveRegistration details
- Analysis ID
- 3e0c851dcdc7ebcf1092e0c15a1d2e22
- Customs Code
- DHA05603213504
Company information
- Manufacturer
- ABBOTT GMBH;; SEKISUI DIAGNOSTICS P.E.I. INC.
- Manufacturer Country
- Canada;;Germany
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product is used on an Alinity c analyzer to quantify direct bilirubin in human serum or plasma.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1110 Bilirubin (total or direct) test system
- Import Information
- Contract manufacturing;; input
Dates and status
- Registration Date
- Jan 25, 2019
- Expiry Date
- Jan 25, 2029
About this record
Access comprehensive regulatory information for Abbec direct bilirubin 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 3e0c851dcdc7ebcf1092e0c15a1d2e22 and manufactured by ABBOTT GMBH;; SEKISUI DIAGNOSTICS P.E.I. INC.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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