21 CFR 862.1110
§ 862.1110 Bilirubin (total or direct) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1110, § 862.1110 Bilirubin (total or direct) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89056
- Permanent ID
ys:prov:89056@1- SHA-256
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Full text
(a) Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
(b) Classification. Class II.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.