Taiwan FDA registration 8593a6d9031f55d294c359e6bf24983b
Abbott second-generation total bilirubin assay set
TW: 亞培第二代總膽紅素檢驗試劑組
Taiwan·Risk Class 2·ABBOTT IRELAND DIAGNOSTICS DIVISION·Registered Sep 21, 2022 – Sep 21, 2027ActiveRegistration details
- Analysis ID
- 8593a6d9031f55d294c359e6bf24983b
- Customs Code
- DHA05603585300
Company information
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Manufacturer Country
- Ireland
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product is used to quantify total bilirubin in human serum or plasma in adults and newborns on the Alinity c System.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1110 Bilirubin (total or direct) test system
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Sep 21, 2022
- Expiry Date
- Sep 21, 2027
About this record
Access comprehensive regulatory information for Abbott second-generation total bilirubin 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 8593a6d9031f55d294c359e6bf24983b and manufactured by ABBOTT IRELAND DIAGNOSTICS DIVISION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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