21 CFR 862.1113 - Bilirubin (total and unbound) in the neonate test system.

Regulations last checked for updates: Feb 12, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart B [§ 862.1020 - § 862.1840]

§ 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.

[54 FR 30206, July 19, 1989]

authority: 21 U.S.C. 351,360,360c,360e,360j,360

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

cite as: 21 CFR 862.1113