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Code of Federal Regulations (Last Updated: November 8, 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 |
| 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. |
| § 864.7295 - Heparin and direct oral factor Xa inhibitor drug test system. |
| § 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 - xxx |
| § 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. |