21 CFR 864.7675 — Test, Leukocyte Peroxidase
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7675
Identification
A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.
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 |
|---|---|---|---|---|
| GIA | Test, Leukocyte Peroxidase | 1 | 3 | |
| LGO | Test, Leukocyte Typing | 1 | 5 | |
| LJX | Test, Urine Leukocyte | 1 | 7 |
