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C.F.R - Table of Contents

  • Title 1 - General Provisions
  • Title 2 - Grants and Agreements
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  • Title 4 - Accounts
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  • Title 50 - Wildlife and Fisheries

CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART J—Products Used In Establishments That Manufacture Blood and Blood Products (§864.9050 to §864.9875)

SUBPART J—Products Used In Establishments That Manufacture Blood and Blood Products (§864.9050 to §864.9875)

  • 864.9050—Blood bank supplies.
  • 864.9100—Empty container for the collection and processing of blood and blood components.
  • 864.9125—Vacuum-assisted blood collection system.
  • 864.9145—Processing system for frozen blood.
  • 864.9160—Blood group substances of nonhuman origin for in vitro diagnostic use.
  • 864.9175—Automated blood grouping and antibody test system.
  • 864.9185—Blood grouping view box.
  • 864.9195—Blood mixing devices and blood weighing devices.
  • 864.9205—Blood and plasma warming device.
  • 864.9225—Cell-freezing apparatus and reagents for in vitro diagnostic use.
  • 864.9245—Automated blood cell separator.
  • 864.9275—Blood bank centrifuge for in vitro diagnostic use.
  • 864.9285—Automated cell-washing centrifuge for immuno-hematology.
  • 864.9300—Automated Coombs test systems.
  • 864.9320—Copper sulfate solution for specific gravity determinations.
  • 864.9400—Stabilized enzyme solution.
  • 864.9550—Lectins and protectins.
  • 864.9575—Environmental chamber for storage of platelet concentrate.
  • 864.9600—Potentiating media for in vitro diagnostic use.
  • 864.9650—Quality control kit for blood banking reagents.
  • 864.9700—Blood storage refrigerator and blood storage freezer.
  • 864.9750—Heat-sealing device.
  • 864.9875—Transfer set.




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