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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 864 - Hematology and Pathology Devices |
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Subpart H - Hematology Kits and Packages |
| § 864.7010 - Flow cytometric test system for hematopoietic neoplasms. |
| § 864.7040 - Adenosine triphosphate release assay. |
| § 864.7060 - Antithrombin III assay. |
| § 864.7100 - Red blood cell enzyme assay. |
| § 864.7140 - Activated whole blood clotting time tests. |
| § 864.7250 - Erythropoietin assay. |
| § 864.7275 - Euglobulin lysis time tests. |
| § 864.7280 - Factor V Leiden DNA mutation detection systems. |
| § 864.7290 - Factor deficiency test. |
| § 864.7300 - Fibrin monomer paracoagulation test. |
| § 864.7320 - Fibrinogen/fibrin degradation products assay. |
| § 864.7340 - Fibrinogen determination system. |
| § 864.7360 - Erythrocytic glucose-6-phosphate dehydrogenase assay. |
| § 864.7375 - Glutathione reductase assay. |
| § 864.7400 - Hemoglobin A2 assay. |
| § 864.7415 - Abnormal hemoglobin assay. |
| § 864.7425 - Carboxyhemoglobin assay. |
| § 864.7440 - Electrophoretic hemoglobin analysis system. |
| § 864.7455 - Fetal hemoglobin assay. |
| § 864.7470 - Glycosylated hemoglobin assay. |
| § 864.7490 - Sulfhemoglobin assay. |
| § 864.7500 - Whole blood hemoglobin assays. |
| § 864.7525 - Heparin assay. |
| § 864.7660 - Leukocyte alkaline phosphatase test. |
| § 864.7675 - Leukocyte peroxidase test. |
| § 864.7695 - Platelet factor 4 radioimmunoassay. |
| § 864.7720 - Prothrombin consumption test. |
| § 864.7735 - Prothrombin-proconvertin test and thrombotest. |
| § 864.7750 - Prothrombin time test. |
| § 864.7825 - Sickle cell test. |
| § 864.7875 - Thrombin time test. |
| § 864.7900 - Thromboplastin generation test. |
| § 864.7925 - Partial thromboplastin time tests. |