21 CFR 864.5260 — Device, Automated Cell-Locating
Hematology (HE) · Part 864 Subpart F—Automated and Semi-Automated Hematology Devices · § 864.5260
Identification
An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JOY | Device, Automated Cell-Locating | 2 | 35 | 3rd Party |
| LNJ | Analyzer, Chromosome, Automated | 2 | 11 |
