Electronic Code of Federal Regulations
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e-CFR data is current as of July 1, 2020 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1115 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§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]