Taiwan FDA registration 5d5b483306c731221f6ed52223a6a26b
Cimosir D Gemini High Sensitivity Reagent
TW: 希摩西爾D雙子高敏感度試劑
Taiwan·Risk Class 2·INSTRUMENTATION LABORATORY CO.;; BIOKIT S.A.·Registered Jan 18, 2013 – Jan 18, 2028ActiveRegistration details
- Analysis ID
- 5d5b483306c731221f6ed52223a6a26b
- Customs Code
- DHA00602431902
Company information
- Manufacturer
- INSTRUMENTATION LABORATORY CO.;; BIOKIT S.A.
- Manufacturer Country
- Spain;;United States
- Authorized Representative
- Werfen Taiwan Limited
Product details
- Intended Use
- Automated latex-enhanced immunoassay for the quantitative detection of D-Dimer in human citrate plasma on the ACL TOP series system.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.7320 Fibrinogen/Fibrinolysis Product Analysis
- Import Information
- Contract manufacturing;; input
Dates and status
- Registration Date
- Jan 18, 2013
- Expiry Date
- Jan 18, 2028
About this record
Access comprehensive regulatory information for Cimosir D Gemini High Sensitivity Reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5d5b483306c731221f6ed52223a6a26b and manufactured by INSTRUMENTATION LABORATORY CO.;; BIOKIT S.A.. The authorized representative in Taiwan is Werfen Taiwan Limited.
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