21 CFR 864.5680 — Analyzer, Heparin, Automated
Hematology (HE) · Part 864 Subpart F—Automated and Semi-Automated Hematology Devices · § 864.5680
Identification
An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.
Classification Rationale
Class II (special controls).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JOX | Analyzer, Heparin, Automated | 2 | 15 | 3rd Party |
Special Controls
JOX — Analyzer, Heparin, Automated
*Classification.* Class II (special controls).
eCFR
