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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 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.
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