Taiwan FDA registration c2e991f16c5d8dee4afbb19838c93614
"Abbott" total bilirubin test set
TW: “亞培” 總膽紅素檢驗試劑組
Taiwan·Risk Class 2·ABBOTT GMBH;; SEKISUI DIAGNOSTICS P.E.I. INC.·Registered Mar 04, 2019 – Mar 04, 2029ActiveRegistration details
- Analysis ID
- c2e991f16c5d8dee4afbb19838c93614
- Customs Code
- DHA05603220002
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 can be used to quantify total bilirubin in serum or plasma in adults and newborns on the Alinity c analyzer.
- 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
- Mar 04, 2019
- Expiry Date
- Mar 04, 2029
About this record
Access comprehensive regulatory information for "Abbott" total 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 c2e991f16c5d8dee4afbb19838c93614 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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