21 CFR 862.3645 - Neuroleptic drugs radioreceptor assay test system.

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There are 2 Updates appearing in the Federal Register for 21 CFR Part 862. View below or at eCFR (GPOAccess)
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.

(a)Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

(b)Classification. Class II.

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United States Code

Title 21 published on 2015-12-03

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

  • 2016-10-04; vol. 81 # 192 - Tuesday, October 4, 2016
    1. 81 FR 68293 - Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 4, 2016.
      21 CFR Part 862

Title 21 published on 2015-12-03.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2016-10-04; vol. 81 # 192 - Tuesday, October 4, 2016
    1. 81 FR 68293 - Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 4, 2016.
      21 CFR Part 862