DADE HEPZYME
Device Facts
| Record ID | K925452 |
|---|---|
| Device Name | DADE HEPZYME |
| Applicant | Baxter Diagnostics, Inc. |
| Product Code | JBR · Hematology |
| Decision Date | Jan 11, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7525 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).
