Taiwan FDA registration 0cffc5f4fb5269656f459b178b0b3b43
HemosIL APTT-SP (Liquid)
TW: 希摩西爾部分凝血活酶時間試劑
Taiwan·Risk Class 2·MD·INSTRUMENTATION LABORATORY CO.·Registered Aug 15, 2018 – Aug 15, 2028ActiveRegistration details
- Analysis ID
- 0cffc5f4fb5269656f459b178b0b3b43
- License Form
- Ministry of Health Medical Device Import No. 031421
- Customs Code
- DHA05603142100
Company information
- Manufacturer
- INSTRUMENTATION LABORATORY CO.
- Manufacturer Country
- United States
- Authorized Representative
- Werfen Taiwan Limited
Product details
- Intended Use
- This product is used with the IL Coagulation System to measure activated partial thromboplastin time (APTT) in vitro on fresh citrate acidified fresh plasma as a general screening procedure to evaluate intrinsic coagulation pathways and monitor patients receiving heparin anticoagulant therapy.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B7925 Partial coagulation time test
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 15, 2018
- Expiry Date
- Aug 15, 2028
About this record
Access comprehensive regulatory information for HemosIL APTT-SP (Liquid) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0cffc5f4fb5269656f459b178b0b3b43 and manufactured by INSTRUMENTATION LABORATORY CO.. The authorized representative in Taiwan is Werfen Taiwan Limited.
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