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

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  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Clinical Chemistry and Clinical Toxicology Devices
  7. Clinical Chemistry Test Systems
  8. Bilirubin (total and unbound) in the neonate test system.

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§ 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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