PBA — Ecarin Clotting Time Class f
FDA product code PBA covers "Ecarin Clotting Time", a Class f medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PBA
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Unknown
- Implant
- No
Definition
The TAS ECT Test Card is to be used with the TAS Analyzer and is intended to determine the anticoagulant effect of hirudin during CBP in patients who have HIT. It is suited for professional use in decentralized areas of testing near the site of patient care as well as for use in the more traditional laboratory. Monitoring with the TAS ECT is indicated for persons who have been identified with and/or confirmed as a high risk for HIT, and require high dose anticoagulant with hirudin for a scheduled or emergency CPB procedure.