21 CFR Subpart H
Hematology Kits and Packages
June 25, 2020
§
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
§
864.7925
Partial thromboplastin time tests
§
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
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