---
kind: "section"
citation: "21 C.F.R. § 862.1113"
title: "21"
number: "862.1113"
heading: "Bilirubin (total and unbound) in the neonate test system."
url: "https://uscodex.org/cfr/21/862.1113"
---

# §862.1113. Bilirubin (total and unbound) in the neonate test system.

- (a) **Identification.** A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
- (b) **Classification.** Class I.

## Notes

### Amendments

[54 FR 30206, July 19, 1989]

### Authority

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

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

### Amendments

[54 FR 30206, July 19, 1989]