21 CFR 864.7525 — Protamine Sulphate
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7525
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).
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GFT | Protamine Sulphate | 2 | 2 | 3rd Party |
| JBR | Test, Heparin Neutralization | 2 | 3 | 3rd Party |
| KFF | Assay, Heparin | 2 | 46 | 3rd Party |
