Adamts13 Activity Test System
- US Product Code (FDA)
- SACView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 864.7297View CFR Regulation →
- Medical specialty
- Hematology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
An ADAMTS13 activity test system is a qualitative or quantitative in vitro diagnostic device intended to detect ADAMTS13 activity in human blood specimens collected from patients being evaluated for thrombotic microangiopathy. This device is indicated to aid in the diagnosis and management of patients being evaluated for thrombotic thrombocytopenic purpura in conjunction with other clinical and laboratory findings.
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Adamts13 Activity Test System is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.