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Code · CFR · Title 21 — Food and Drugs · Part 864 — Hematology and Pathology Devices · § 864.7825

§ 864.7825. Sickle cell test.

41 words·~1 min read·/us/cfr/t21/s§ 864.7825·

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(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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