Taiwan FDA registration 27747d3c75f6eca33624180d36178363
HemosIL ReadiPlasTin
TW: 希摩西爾凝血酶原時間-纖維蛋白原試劑
Taiwan·Risk Class 2·MD·INSTRUMENTATION LABORATORY CO.·Registered Oct 18, 2018 – Oct 18, 2028ActiveRegistration details
- Analysis ID
- 27747d3c75f6eca33624180d36178363
- License Form
- Ministry of Health Medical Device Import No. 031739
- Customs Code
- DHA05603173905
Company information
- Manufacturer
- INSTRUMENTATION LABORATORY CO.
- Manufacturer Country
- United States
- Authorized Representative
- Werfen Taiwan Limited
Product details
- Intended Use
- This product is an in vitro diagnostic thrombin kinase reagent manufactured using recombinant human tissue factors for the quantitative analysis of prothrombin time (PT) and fibrinogen in citrate-treated human plasma. This product is required for use with ACL TOP series analyzers.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B7340 Fibrinogen Confirmation System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 18, 2018
- Expiry Date
- Oct 18, 2028
About this record
Access comprehensive regulatory information for HemosIL ReadiPlasTin in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 27747d3c75f6eca33624180d36178363 and manufactured by INSTRUMENTATION LABORATORY CO.. The authorized representative in Taiwan is Werfen Taiwan Limited.
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