§862.1113. Bilirubin (total and unbound) in the neonate test system.
21 C.F.R. § 862.1113
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).
Classification. Class I.
Notes, amendments, and revision history
Amendments
[54 FR 30206, July 19, 1989]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 16122, May 1, 1987, unless otherwise noted.
Amendments
[54 FR 30206, July 19, 1989]