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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
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 | 864.1 | Scope. |
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| 864.3 | Effective dates of requirement for premarket approval. |
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| 864.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 864.1850 | Dye and chemical solution stains. |
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| 864.1860 | Immunohistochemistry reagents and kits. |
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| 864.2220 | Synthetic cell and tissue culture media and components. |
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| 864.2240 | Cell and tissue culture supplies and equipment. |
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| 864.2260 | Chromosome culture kit. |
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| 864.2280 | Cultured animal and human cells. |
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| 864.2360 | Mycoplasma detection media and components. |
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| 864.2800 | Animal and human sera. |
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| 864.2875 | Balanced salt solutions or formulations. |
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| 864.3010 | Tissue processing equipment. |
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| 864.3250 | Specimen transport and storage container. |
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| 864.3300 | Cytocentrifuge. |
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| 864.3400 | Device for sealing microsections. |
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| 864.3600 | Microscopes and accessories. |
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| 864.3800 | Automated slide stainer. |
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| 864.3875 | Automated tissue processor. |
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| 864.4010 | General purpose reagent. |
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| 864.4020 | Analyte specific reagents. |
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| 864.4400 | Enzyme preparations. |
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| 864.5200 | Automated cell counter. |
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| 864.5220 | Automated differential cell counter. |
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| 864.5240 | Automated blood cell diluting apparatus. |
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| 864.5260 | Automated cell-locating device. |
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| 864.5300 | Red cell indices device. |
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| 864.5350 | Microsedimentation centrifuge. |
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| 864.5400 | Coagulation instrument. |
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| 864.5425 | Multipurpose system for in vitro coagulation studies. |
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| 864.5600 | Automated hematocrit instrument. |
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| 864.5620 | Automated hemoglobin system. |
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| 864.5680 | Automated heparin analyzer. |
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| 864.5700 | Automated platelet aggregation system. |
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| 864.5800 | Automated sedimentation rate device. |
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| 864.5850 | Automated slide spinner. |
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| 864.5950 | Blood volume measuring device. |
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| 864.6100 | Bleeding time device. |
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| 864.6150 | Capillary blood collection tube. |
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| 864.6160 | Manual blood cell counting device. |
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| 864.6400 | Hematocrit measuring device. |
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| 864.6550 | Occult blood test. |
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| 864.6600 | Osmotic fragility test. |
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| 864.6650 | Platelet adhesion test. |
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| 864.6675 | Platelet aggregometer. |
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| 864.6700 | Erythrocyte sedimentation rate test. |
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| 864.7040 | Adenosine triphosphate release assay. |
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| 864.7060 | Antithrombin III assay. |
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| 864.7100 | Red blood cell enzyme assay. |
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| 864.7140 | Activated whole blood clotting time tests. |
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| 864.7250 | Erythropoietin assay. |
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| 864.7250 | Erythropoietin assay. |
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| 864.7275 | Euglobulin lysis time tests. |
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| 864.7290 | Factor deficiency test. |
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| 864.7300 | Fibrin monomer paracoagulation test. |
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| 864.7300 | Fibrin monomer paracoagulation test. |
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| 864.7320 | Fibrinogen/fibrin degradation products assay. |
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| 864.7340 | Fibrinogen determination system. |
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| 864.7360 | Erythrocytic glucose-6-phosphate dehydrogenase assay. |
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| 864.7375 | Glutathione reductase assay. |
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| 864.7400 | Hemoglobin A2 assay. |
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| 864.7415 | Abnormal hemoglobin assay. |
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| 864.7425 | Carboxyhemoglobin assay. |
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| 864.7440 | Electrophoretic hemoglobin analysis system. |
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| 864.7455 | Fetal hemoglobin assay. |
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| 864.7470 | Glycosylated hemoglobin assay. |
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| 864.7490 | Sulfhemoglobin assay. |
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| 864.7500 | Whole blood hemoglobin assays. |
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| 864.7525 | Heparin assay. |
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| 864.7660 | Leukocyte alkaline phosphatase test. |
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| 864.7675 | Leukocyte peroxidase test. |
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| 864.7695 | Platelet factor 4 radioimmunoassay. |
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| 864.7720 | Prothrombin consumption test. |
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| 864.7735 | Prothrombin-proconvertin test and thrombotest. |
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| 864.7750 | Prothrombin time test. |
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| 864.7825 | Sickle cell test. |
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| 864.7875 | Thrombin time test. |
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| 864.7900 | Thromboplastin generation test. |
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| 864.7925 | Partial thromboplastin time tests. |
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| 864.8100 | Bothrops atrox reagent. |
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| 864.8150 | Calibrator for cell indices. |
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| 864.8165 | Calibrator for hemoglobin or hematocrit measurement. |
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| 864.8175 | Calibrator for platelet counting. |
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| 864.8185 | Calibrator for red cell and white cell counting. |
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| 864.8200 | Blood cell diluent. |
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| 864.8500 | Lymphocyte separation medium. |
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| 864.8540 | Red cell lysing reagent. |
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| 864.8625 | Hematology quality control mixture. |
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| 864.8950 | Russell viper venom reagent. |
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| 864.9050 | Blood bank supplies. |
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| 864.9100 | Empty container for the collection and processing of blood and blood components. |
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| 864.9125 | Vacuum-assisted blood collection system. |
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| 864.9145 | Processing system for frozen blood. |
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| 864.9160 | Blood group substances of nonhuman origin for in vitro diagnostic use. |
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| 864.9175 | Automated blood grouping and antibody test system. |
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| 864.9185 | Blood grouping view box. |
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| 864.9195 | Blood mixing devices and blood weighing devices. |
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| 864.9205 | Blood and plasma warming device. |
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| 864.9225 | Cell-freezing apparatus and reagents for in vitro diagnostic use. |
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| 864.9245 | Automated blood cell separator. |
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| 864.9275 | Blood bank centrifuge for in vitro diagnostic use. |
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| 864.9285 | Automated cell-washing centrifuge for immuno-hematology. |
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| 864.9300 | Automated Coombs test systems. |
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| 864.9320 | Copper sulfate solution for specific gravity determinations. |
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| 864.9400 | Stabilized enzyme solution. |
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| 864.9550 | Lectins and protectins. |
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| 864.9575 | Environmental chamber for storage of platelet concentrate. |
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| 864.9600 | Potentiating media for in vitro diagnostic use. |
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| 864.9650 | Quality control kit for blood banking reagents. |
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| 864.9700 | Blood storage refrigerator and blood storage freezer. |
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| 864.9750 | Heat-sealing device. |
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| 864.9875 | Transfer set. |
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