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Regulations last checked for updates: May 14, 2025

Title 21 - Food and Drugs last revised: May 12, 2025
All TitlesTitle 21Chapter IPart 864Subpart F - Subpart F—Automated and Semi-Automated Hematology Devices
  • § 864.5200 - Automated cell counter.
  • § 864.5220 - Automated differential cell counter.
  • § 864.5240 - Automated blood cell diluting apparatus.
  • § 864.5260 - Automated cell-locating device.
  • § 864.5300 - Red cell indices device.
  • § 864.5350 - Microsedimentation centrifuge.
  • § 864.5400 - Coagulation instrument.
  • § 864.5425 - Multipurpose system for in vitro coagulation studies.
  • § 864.5430 - Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients.
  • § 864.5600 - Automated hematocrit instrument.
  • § 864.5620 - Automated hemoglobin system.
  • § 864.5680 - Automated heparin analyzer.
  • § 864.5700 - Automated platelet aggregation system.
  • § 864.5800 - Automated sedimentation rate device.
  • § 864.5850 - Automated slide spinner.
  • § 864.5950 - Blood volume measuring device.
authority: 21 U.S.C. 351,360,360c,360e,360j,360
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