---
kind: "section"
citation: "21 C.F.R. § 866.3940"
title: "21"
number: "866.3940"
heading: "West Nile virus serological reagents."
url: "https://uscodex.org/cfr/21/866.3940"
---

# §866.3940. West Nile virus serological reagents.

- (a) **Identification.** West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus.
- (b) **Classification.** Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus.” See [§ 866.1(e)](/cfr/21/866.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[68 FR 61745, Oct. 30, 2003]

### 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

[68 FR 61745, Oct. 30, 2003]