21 CFR 864.9285 — Centrifuge, Cell-Washing, Automated For Immuno-Hematology
Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9285
Identification
An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KSN | Centrifuge, Cell-Washing, Automated For Immuno-Hematology | 2 | 1 |
