21 CFR 864.9225 — Apparatus, Cell-Freezing And Reagents
Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9225
Identification
Cell-freezing apparatus and reagents for in vitro diagnostic use are devices used to freeze human red blood cells for in vitro diagnostic use.
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 |
|---|---|---|---|---|
| KSP | Apparatus, Cell-Freezing And Reagents | 1 | 1 |
