1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 864 - HEMATOLOGY AND PATHOLOGY DEVICES
  6. Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products
  7. 21 CFR § 864.9285
21 CFR § 864.9285
Automated cell-washing centrifuge for immuno-hematology
June 25, 2020
CFR

(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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§ 864.9275 Blood bank centrifuge for in vitro diagnostic use
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§ 864.9300 Automated Coombs test systems

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