Taiwan FDA registration 1683047b3a79521bb2516eb940f9548c
Abbott Alinity c Clinical Chemistry Controls Kit
TW: 亞培臨床生化品管液組
Taiwan·Risk Class 2·MD·SENTINEL CH. S.p.A.·Registered Jul 14, 2020 – Jul 14, 2025ExpiredRegistration details
- Analysis ID
- 1683047b3a79521bb2516eb940f9548c
- License Form
- Ministry of Health Medical Device Import No. 033506
- Customs Code
- DHA05603350605
Company information
- Manufacturer
- SENTINEL CH. S.p.A.
- Manufacturer Country
- Italy
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product is used to verify the performance of the following Alinity c analyses: bilinoesterase, creatinine (enzyme assay), debukacaine cholinesterase , oxybutyrate dehydrogenase, iron, lithium and pancreatic amylase.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1660 Quality Control Materials (Analytical and Non-Analytical)
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 14, 2020
- Expiry Date
- Jul 14, 2025
About this record
Access comprehensive regulatory information for Abbott Alinity c Clinical Chemistry Controls Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1683047b3a79521bb2516eb940f9548c and manufactured by SENTINEL CH. S.p.A.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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