Products Used In Establishments That Manufacture Blood and Blood Products

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Hematology and Pathology Devices
  7. Products Used In Establishments That Manufacture Blood and Blood Products

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Section
864.9050

Blood bank supplies.

Section
864.9100

Empty container for the collection and processing of blood and blood components.

Section
864.9125

Vacuum-assisted blood collection system.

Section
864.9145

Processing system for frozen blood.

Section
864.9160

Blood group substances of nonhuman origin for in vitro diagnostic use.

Section
864.9165

Blood establishment computer software and accessories.

Section
864.9175

Automated blood grouping and antibody test system.

Section
864.9185

Blood grouping view box.

Section
864.9195

Blood mixing devices and blood weighing devices.

Section
864.9205

Blood and plasma warming device.

Section
864.9225

Cell-freezing apparatus and reagents for in vitro diagnostic use.

Section
864.9245

Automated blood cell separator.

Section
864.9275

Blood bank centrifuge for in vitro diagnostic use.

Section
864.9285

Automated cell-washing centrifuge for immuno-hematology.

Section
864.9300

Automated Coombs test systems.

Section
864.9320

Copper sulfate solution for specific gravity determinations.

Section
864.9400

Stabilized enzyme solution.

Section
864.9550

Lectins and protectins.

Section
864.9575

Environmental chamber for storage of platelet concentrate.

Section
864.9600

Potentiating media for in vitro diagnostic use.

Section
864.9650

Quality control kit for blood banking reagents.

Section
864.9700

Blood storage refrigerator and blood storage freezer.

Section
864.9750

Heat-sealing device.

Section
864.9875

Transfer set.