21 CFR 864.5700 — Reagent, Platelet Aggregation
Hematology (HE) · Part 864 Subpart F—Automated and Semi-Automated Hematology Devices · § 864.5700
Identification
An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GHR | Reagent, Platelet Aggregation | 2 | 11 | 3rd Party |
| JOZ | System, Automated Platelet Aggregation | 2 | 38 | 3rd Party |
| OBW | 11-Dehydro Thromboxane B2 Kit, Urinary | 2 | 1 | 3rd Party |
