21 CFR 862.3700 - Propoxyphene test system.

§ 862.3700 Propoxyphene test system.

(a)Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.

(b)Classification. Class II.

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United States Code

Title 21 published on 09-Nov-2018 03:23

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 862 after this date.

  • 2018-11-01; vol. 83 # 212 - Thursday, November 1, 2018
    1. 83 FR 54873 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective November 1, 2018. The classification was applicable on June 12, 2018.
      21 CFR Part 862