Taiwan FDA registration 1120768ac114e4c319c5b63c9de22bd6
Abbott clinical biochemical direct bilirubin test group
TW: 亞培臨床生化直接膽紅素檢驗試劑組
Taiwan·Risk Class 2·ABBOTT GMBH;; SEKISUI DIAGNOSTICS P.E.I. INC.·Registered Mar 19, 2012 – Mar 19, 2027ActiveRegistration details
- Analysis ID
- 1120768ac114e4c319c5b63c9de22bd6
- Customs Code
- DHA00602335906
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
- The quantitative measurement of direct bilirubin concentration in human serum or plasma should be used with the ARCHITECT c system (c 4000, c 8000, c16000) and the AEROSET 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;; Contract manufacturing
Dates and status
- Registration Date
- Mar 19, 2012
- Expiry Date
- Mar 19, 2027
About this record
Access comprehensive regulatory information for Abbott clinical biochemical direct bilirubin 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 1120768ac114e4c319c5b63c9de22bd6 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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