Sickle cell test.

  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. Hematology Kits and Packages
  8. Sickle cell test.

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§ 864.7825 Sickle cell test.

(a) Identification. A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.

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

[45 FR 60627, Sept. 12, 1980]


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