Code of Federal Regulations · Section

§ 862.1113 — Bilirubin (total And Unbound) In The Neonate Test System

21 C.F.R. § 862.1113

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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.

21 C.F.R. § 862.1110 21 C.F.R. § 862.1115

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