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21 CFR 862.1113

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

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 862.1113, § 862.1113 Bilirubin (total and unbound) in the neonate test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89057
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(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.