21 CFR § 862.1113 Clinical Chemistry and Clinical Toxicology Devices

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

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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]

← § 862.1110 Bilirubin (total or direct) test system.§ 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system. →