21 CFR 864.8185 — Calibrator For Red-Cell And White-Cell Counting
Hematology (HE) · Part 864 Subpart I—Hematology Reagents · § 864.8185
Identification
A calibrator for red cell and white cell counting is a device that resembles red or white blood cells and that is used to set instruments intended to count red cells, white cells, or both. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.
Classification Rationale
Class II (special controls). The 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 |
|---|---|---|---|---|
| KSA | Calibrator For Red-Cell And White-Cell Counting | 2 | 8 |
Special Controls
KSA — Calibrator For Red-Cell And White-Cell Counting
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
