---
kind: "section"
citation: "21 C.F.R. § 866.4100"
title: "21"
number: "866.4100"
heading: "Complement reagent."
url: "https://uscodex.org/cfr/21/866.4100"
---

# §866.4100. Complement reagent.

- (a) **Identification.** A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.
- (b) **Classification.** Class I (general 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 [§ 866.9](/cfr/21/866.9.md).

## Notes

### Amendments

[47 FR 50823, Nov. 9, 2001, as amended at 66 FR 38792, July 25, 2001]

### Authority

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

### Source

Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

### Amendments

[47 FR 50823, Nov. 9, 2001, as amended at 66 FR 38792, July 25, 2001]