21 CFR 862.1785
§ 862.1785 Urinary urobilinogen (nonquantitative) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1785, § 862.1785 Urinary urobilinogen (nonquantitative) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89200
- Permanent ID
ys:prov:89200@1- SHA-256
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Full text
(a) Identification. A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.