21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1113

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

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Regulatory Text

21 C.F.R. § 862.1113 — Bilirubin (total and unbound) in the neonate test system.

§ 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]

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21 C.F.R. § 862.1113
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The regulatory text of 21 C.F.R. § 862.1113 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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