Automated cell-washing centrifuge for immuno-hematology.

  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
  8. Automated cell-washing centrifuge for immuno-hematology.

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§ 864.9285 Automated cell-washing centrifuge for immuno-hematology.

(a) Identification. An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing.

(b) Classification. Class II (performance standards).

[45 FR 60646, Sept. 12, 1980]


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