21 CFR 864.8500 — Lymphocyte Separation Medium
Hematology (HE) · Part 864 Subpart I—Hematology Reagents · § 864.8500
Identification
A lymphocyte separation medium is a device used to isolate lymphocytes from whole blood.
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 |
|---|---|---|---|---|
| JCF | Lymphocyte Separation Medium | 1 | 12 |
