Taiwan FDA registration 0aaff72cf3c1815399f45b83e9e488aa
HemosIL Liquid Anti-Xa
TW: 希摩西爾液態抗活化第十因子試驗組
Taiwan·Risk Class 2·MD·INSTRUMENTATION LABORATORY CO.·Registered Oct 29, 2018 – Oct 29, 2028ActiveRegistration details
- Analysis ID
- 0aaff72cf3c1815399f45b83e9e488aa
- License Form
- Ministry of Health Medical Device Import No. 031764
- Customs Code
- DHA05603176404
Company information
- Manufacturer
- INSTRUMENTATION LABORATORY CO.
- Manufacturer Country
- United States
- Authorized Representative
- Werfen Taiwan Limited
Product details
- Intended Use
- This product is used by IL agglutination system (ACL TOP Family and ELITE PRO) with HemosIL heparin correction solution (HemosIL Heparin Calibrators) to quantify the activity of traditional heparin (UFH) and low molecular weight heparin (LMWH) in human plasma after citrate treatment. This product is also used to measure the concentration of direct inhibitors of factor Xa (e.g., Rivaroxaban, Apixaban) in human plasma after citrate treatment with HemosIL Rivaroxaban Correction Solution (for Rivaroxaban test) and HemosIL Apixaban Correction Solution (for Apixaban Test) after citrate treatment.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B7525 Heparin analysis
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 29, 2018
- Expiry Date
- Oct 29, 2028
About this record
Access comprehensive regulatory information for HemosIL Liquid Anti-Xa in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0aaff72cf3c1815399f45b83e9e488aa and manufactured by INSTRUMENTATION LABORATORY CO.. The authorized representative in Taiwan is Werfen Taiwan Limited.
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