21 CFR 864.9275 — Centrifuge, Blood-Bank For In Vitro Diagnostic Use
Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9275
Identification
A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic testing.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KSO | Centrifuge, Blood-Bank For In Vitro Diagnostic Use | 1 | 1 |
