---
kind: "section"
citation: "21 C.F.R. § 866.3040"
title: "21"
number: "866.3040"
heading: "Aspergillus spp. serological reagents."
url: "https://uscodex.org/cfr/21/866.3040"
---

# §866.3040. Aspergillus spp. serological reagents.

- (a) **Identification. Aspergillus—** spp. serological reagents are devices that consist of antigens and antisera used in various serological tests to identify antibodies to Aspergillus spp. in serum. The identification aids in the diagnosis of aspergillosis caused by fungi belonging to the genus Aspergillus. Aspergillosis is a disease marked by inflammatory granulomatous (tumor-like) lessions in the skin, ear, eyeball cavity, nasal sinuses, lungs, and occasionally the bones.
- (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 2311, 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 2311, Jan. 14, 2000]