Taiwan FDA registration 8400fc5945c88d9a853be697702dbdc8
Abbott D-dimer Assay Set
TW: 亞培 D-二聚體檢驗試劑組
Taiwan·Risk Class 2·BIOKIT, S.A.·Registered Dec 15, 2023 – Dec 15, 2028ActiveRegistration details
- Analysis ID
- 8400fc5945c88d9a853be697702dbdc8
- Customs Code
- DHA05603624202
Company information
- Manufacturer
- BIOKIT, S.A.
- Manufacturer Country
- Spain
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product is intended for the quantitative detection of D-dimer in human citrate plasma on the Alinity c System
- Product Type (Level 1)
- B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.7320 Analysis of pro-fiber/fiber-based protein disintegration products
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Dec 15, 2023
- Expiry Date
- Dec 15, 2028
About this record
Access comprehensive regulatory information for Abbott D-dimer 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 8400fc5945c88d9a853be697702dbdc8 and manufactured by BIOKIT, S.A.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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