21 CFR 864.6650 — Study, Platelet Adhesive
Hematology (HE) · Part 864 Subpart G—Manual Hematology Devices · § 864.6650
Identification
A platelet adhesion test is a device used to determine in vitro platelet function.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JBZ | Study, Platelet Adhesive | 2 | 3 |
