21 CFR 864.8200 — Fluid, Diluting, White-Cell
Hematology (HE) · Part 864 Subpart I—Hematology Reagents · § 864.8200
Identification
A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GGJ | Fluid, Diluting, White-Cell | 1 | 1 | |
| GIF | Diluent, Blood Cell | 1 | 38 | |
| GJN | Fluid, Diluting, Red-Cell | 1 | 0 | |
| JCG | Fluid, Diluting, Manual Cell | 1 | 1 |
