21 CFR § 864.7825
Sickle cell test
June 25, 2020
(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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