SAC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Adamts13 Activity Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7297
- Medical specialty
- Hematology
- FDA definition
- 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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| Record | Firm | Date | Builder |
|---|---|---|---|
| Technozym ADAMTS13 Activity (DEN230024) | Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM | 2024-02-28 |
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