---
kind: "section"
citation: "21 C.F.R. § 866.5510"
title: "21"
number: "866.5510"
heading: "Immunoglobulins A, G, M, D, and E immunological test system."
url: "https://uscodex.org/cfr/21/866.5510"
---

# §866.5510. Immunoglobulins A, G, M, D, and E immunological test system.

- (a) **Identification.** An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
- (b) **Classification.** Class II (performance standards).

## Notes

### 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.