Urinary bilirubin and its conjugates (nonquantitative) test system.

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Clinical Chemistry and Clinical Toxicology Devices
  7. Clinical Chemistry Test Systems
  8. Urinary bilirubin and its conjugates (nonquantitative) test system.

Checkout our iOS App for a better way to browser and research.

§ 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]


Download our app to see the most-to-date content.