21 CFR 864.7825 — Test, Sickle Cell
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7825
Identification
A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GHM | Test, Sickle Cell | 2 | 18 | 3rd Party |
| JBB | Solubility, Hemoglobin, Abnormal | 2 | 2 | 3rd Party |
