21 CFR 864.5300 — Red-Cell Indices, Measured
Hematology (HE) · Part 864 Subpart F—Automated and Semi-Automated Hematology Devices · § 864.5300
Identification
A red cell indices device, usually part of a larger system, calculates or directly measures the erythrocyte mean corpuscular volume (MCV), the mean corpuscular hemoglobin (MCH), and the mean corpuscular hemoglobin concentration (MCHC). The red cell indices are used for the differential diagnosis of anemias.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JBW | Red-Cell Indices, Measured | 2 | 0 | 3rd Party |
| JPJ | Red-Cell Indices, Calculated | 2 | 3 | 3rd Party |
| KQH | Red-Cell Indices | 2 | 1 | 3rd Party |
