21 CFR § 862.1115 - Urinary bilirubin and its conjugates (nonquantitative) test system.

---
identifier: "/us/cfr/t21/s862.1115"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1115 - Urinary bilirubin and its conjugates (nonquantitative) test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1115"
section_name: "Urinary bilirubin and its conjugates (nonquantitative) test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system.

(a) *Identification.* A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.

(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.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]