Taiwan FDA registration b5190488c233b50118adc893f86265db
VerifyNow PRUTest
TW: “即刻確認”血小板凝集反應檢驗系統試劑組
Taiwan·Risk Class 2·MD·Accriva Diagnostics Inc.·Registered Oct 14, 2019 – Oct 14, 2024ExpiredRegistration details
- Analysis ID
- b5190488c233b50118adc893f86265db
- License Form
- Ministry of Health Medical Device Import No. 032937
- Customs Code
- DHA05603293701
Company information
- Manufacturer
- Accriva Diagnostics Inc.
- Manufacturer Country
- United States
- Authorized Representative
- Werfen Taiwan Limited
Product details
- Intended Use
- This product must be used with the VerifyNow System, which can be used in the laboratory or designated care unit to measure the blockade of platelet P2Y12 receptors using a whole blood test, and is restricted to professionals.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B5700 Automated platelet agglutination system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 14, 2019
- Expiry Date
- Oct 14, 2024
About this record
Access comprehensive regulatory information for VerifyNow PRUTest in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b5190488c233b50118adc893f86265db and manufactured by Accriva Diagnostics Inc.. The authorized representative in Taiwan is Werfen Taiwan Limited.
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