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Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1113 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§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]