21 CFR 864.8540 — Products, Red-Cell Lysing Products
Hematology (HE) · Part 864 Subpart I—Hematology Reagents · § 864.8540
Identification
A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
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 |
|---|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | 1 | 29 |
