SAC — Adamts13 Activity Test System Class II
Classification Details
- Product Code
- SAC
- Device Class
- Class II
- Regulation Number
- 864.7297
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230024 | technoclone herstellung von diagnostika und arzneimitteln gm | Technozym ADAMTS13 Activity | February 28, 2024 |