---
kind: "section"
citation: "21 C.F.R. § 864.8165"
title: "21"
number: "864.8165"
heading: "Calibrator for hemoglobin or hematocrit measurement."
url: "https://uscodex.org/cfr/21/864.8165"
---

# §864.8165. Calibrator for hemoglobin or hematocrit measurement.

- (a) **Identification.** A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.
- (b) **Classification.** Class II (special controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 864.9](/cfr/21/864.9.md).

## Notes

### Amendments

[45 FR 60632, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]

### Authority

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

### Amendments

[45 FR 60632, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]