21 CFR Subpart H - 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.