Automated platelet aggregation system.

  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. Automated and Semi-Automated Hematology Devices
  8. Automated platelet aggregation system.

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§ 864.5700 Automated platelet aggregation system.

(a) Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.

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

[45 FR 60602, Sept. 12, 1980]


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