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Code · CFR · Title 21 — Food and Drugs · Part 862 — Clinical Chemistry and Clinical Toxicology Devices · § 862.1113

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

52 words·~1 min read·/us/cfr/t21/s§ 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. [54 FR 30206, July 19, 1989]
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§ 862.1113
Bilirubin (total and unbound) in the neonate test system.
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