TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
Subpart A - General Provisions
§ 864.1 - Scope.
§ 864.3 - Effective dates of requirement for premarket approval.
§ 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart B - Biological Stains
§ 864.1850 - Dye and chemical solution stains.
§ 864.1860 - Immunohistochemistry reagents and kits.
§ 864.1865 - Cervical intraepithelial neoplasia (CIN) test system.
§ 864.1866 - Lynch syndrome test systems.
§ 864.1870 - Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.
Subpart C - Cell And Tissue Culture Products
§ 864.2220 - Synthetic cell and tissue culture media and components.
§ 864.2240 - Cell and tissue culture supplies and equipment.
§ 864.2260 - Chromosome culture kit.
§ 864.2280 - Cultured animal and human cells.
§ 864.2360 - Mycoplasma detection media and components.
§ 864.2800 - Animal and human sera.
§ 864.2875 - Balanced salt solutions or formulations.
Subpart D - Pathology Instrumentation and Accessories
§ 864.3010 - Tissue processing equipment.
§ 864.3250 - Specimen transport and storage container.
§ 864.3260 - OTC test sample collection systems for drugs of abuse testing.
§ 864.3300 - Cytocentrifuge.
§ 864.3400 - Device for sealing microsections.
§ 864.3600 - Microscopes and accessories.
§ 864.3700 - Whole slide imaging system.
§ 864.3750 - Software algorithm device to assist users in digital pathology.
§ 864.3800 - Automated slide stainer.
§ 864.3875 - Automated tissue processor.
Subpart E - Specimen Preparation Reagents
§ 864.4010 - General purpose reagent.
§ 864.4020 - Analyte specific reagents.
§ 864.4400 - Enzyme preparations.
Subpart F - Automated and Semi-Automated Hematology Devices
§ 864.5200 - Automated cell counter.
§ 864.5220 - Automated differential cell counter.
§ 864.5240 - Automated blood cell diluting apparatus.
§ 864.5260 - Automated cell-locating device.
§ 864.5300 - Red cell indices device.
§ 864.5350 - Microsedimentation centrifuge.
§ 864.5400 - Coagulation instrument.
§ 864.5425 - Multipurpose system for in vitro coagulation studies.
§ 864.5600 - Automated hematocrit instrument.
§ 864.5620 - Automated hemoglobin system.
§ 864.5680 - Automated heparin analyzer.
§ 864.5700 - Automated platelet aggregation system.
§ 864.5800 - Automated sedimentation rate device.
§ 864.5850 - Automated slide spinner.
§ 864.5950 - Blood volume measuring device.
Subpart G - Manual Hematology Devices
§ 864.6100 - Bleeding time device.
§ 864.6150 - Capillary blood collection tube.
§ 864.6160 - Manual blood cell counting device.
§ 864.6400 - Hematocrit measuring device.
§ 864.6550 - Occult blood test.
§ 864.6600 - Osmotic fragility test.
§ 864.6650 - Platelet adhesion test.
§ 864.6675 - Platelet aggregometer.
§ 864.6700 - Erythrocyte sedimentation rate test.
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.
Subpart I - Hematology Reagents
§ 864.8100 - Bothrops atrox reagent.
§ 864.8150 - Calibrator for cell indices.
§ 864.8165 - Calibrator for hemoglobin or hematocrit measurement.
§ 864.8175 - Calibrator for platelet counting.
§ 864.8185 - Calibrator for red cell and white cell counting.
§ 864.8200 - Blood cell diluent.
§ 864.8500 - Lymphocyte separation medium.
§ 864.8540 - Red cell lysing reagent.
§ 864.8625 - Hematology quality control mixture.
§ 864.8950 - Russell viper venom reagent.
Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products
§ 864.9050 - Blood bank supplies.
§ 864.9100 - Empty container for the collection and processing of blood and blood components.
§ 864.9115 - Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.
§ 864.9125 - Vacuum-assisted blood collection system.
§ 864.9145 - Processing system for frozen blood.
§ 864.9160 - Blood group substances of nonhuman origin for in vitro diagnostic use.
§ 864.9165 - Blood establishment computer software and accessories.
§ 864.9175 - Automated blood grouping and antibody test system.
§ 864.9185 - Blood grouping view box.
§ 864.9195 - Blood mixing devices and blood weighing devices.
§ 864.9205 - Blood and plasma warming device.
§ 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.
§ 864.9245 - Automated blood cell separator.
§ 864.9275 - Blood bank centrifuge for in vitro diagnostic use.
§ 864.9285 - Automated cell-washing centrifuge for immuno-hematology.
§ 864.9300 - Automated Coombs test systems.
§ 864.9320 - Copper sulfate solution for specific gravity determinations.
§ 864.9400 - Stabilized enzyme solution.
§ 864.9550 - Lectins and protectins.
§ 864.9575 - Environmental chamber for storage of platelet concentrate.
§ 864.9600 - Potentiating media for in vitro diagnostic use.
§ 864.9650 - Quality control kit for blood banking reagents.
§ 864.9700 - Blood storage refrigerator and blood storage freezer.
§ 864.9750 - Heat-sealing device.
§ 864.9875 - Transfer set.
Subpart K - Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
§ 864.9900 - Cord blood processing system and storage container.
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