---
kind: "section"
citation: "21 C.F.R. § 866.3500"
title: "21"
number: "866.3500"
heading: "Rickettsia serological reagents."
url: "https://uscodex.org/cfr/21/866.3500"
---

# §866.3500. Rickettsia serological reagents.

- (a) **Identification.** Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genus Rickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).
- (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 [§ 866.9](/cfr/21/866.9.md).

## Notes

### Amendments

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]

### 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, 1982, as amended at 65 FR 2312, Jan. 14, 2000]