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Title 21

Displaying title 21, up to date as of 7/08/2026. Title 21 was last amended 7/07/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 864Hematology and Pathology Devices864.1 – 864.9900
Subpart HHematology Kits and Packages864.7010 – 864.7925
§ 864.7010Flow cytometric test system for hematopoietic neoplasms.
§ 864.7040Adenosine triphosphate release assay.
§ 864.7060Antithrombin III assay.
§ 864.7100Red blood cell enzyme assay.
§ 864.7140Activated whole blood clotting time tests.
§ 864.7250Erythropoietin assay.
§ 864.7275Euglobulin lysis time tests.
§ 864.7280Factor V Leiden DNA mutation detection systems.
§ 864.7290Factor deficiency test.
§ 864.7293Von Willebrand factor assay.
§ 864.7295Heparin and direct oral factor Xa inhibitor drug test system.
§ 864.7300Fibrin monomer paracoagulation test.
§ 864.7320Fibrinogen/fibrin degradation products assay.
§ 864.7340Fibrinogen determination system.
§ 864.7360Erythrocytic glucose-6-phosphate dehydrogenase assay.
§ 864.7375Glutathione reductase assay.
§ 864.7400Hemoglobin A2 assay.
§ 864.7415Abnormal hemoglobin assay.
§ 864.7425Carboxyhemoglobin assay.
§ 864.7440Electrophoretic hemoglobin analysis system.
§ 864.7455Fetal hemoglobin assay.
§ 864.7470Glycosylated hemoglobin assay.
§ 864.7490Sulfhemoglobin assay.
§ 864.7500Whole blood hemoglobin assays.
§ 864.7525Heparin assay.
§ 864.7660Leukocyte alkaline phosphatase test.
§ 864.7675Leukocyte peroxidase test.
§ 864.7695Platelet factor 4 radioimmunoassay.
§ 864.7720Prothrombin consumption test.
§ 864.7735Prothrombin-proconvertin test and thrombotest.
§ 864.7750Prothrombin time test.
§ 864.7825Sickle cell test.
§ 864.7875Thrombin time test.
§ 864.7900Thromboplastin generation test.
§ 864.7925Partial thromboplastin time tests.