1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
  6. Subpart B - Clinical Chemistry Test Systems
  7. 21 CFR § 862.1113
21 CFR § 862.1113
Bilirubin (total and unbound) in the neonate test system
June 25, 2020
CFR

(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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§ 862.1110 Bilirubin (total or direct) test system
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§ 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system

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