Title 21

SECTION 862.1113

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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