---
kind: "section"
citation: "21 C.F.R. § 864.8540"
title: "21"
number: "864.8540"
heading: "Red cell lysing reagent."
url: "https://uscodex.org/cfr/21/864.8540"
---

# §864.8540. Red cell lysing reagent.

- (a) **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.
- (b) **Classification.** Class I (general controls). This 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 60636, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]

### Authority

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

### Amendments

[45 FR 60636, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]