---
kind: "section"
citation: "21 C.F.R. § 864.7825"
title: "21"
number: "864.7825"
heading: "Sickle cell test."
url: "https://uscodex.org/cfr/21/864.7825"
---

# §864.7825. Sickle cell test.

- (a) **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.
- (b) **Classification.** Class II (performance standards).

## Notes

### Amendments

[45 FR 60627, Sept. 12, 1980]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Amendments

[45 FR 60627, Sept. 12, 1980]