21 CFR Part 864
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
- PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
- 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.
- § 864.1880 Fluorescence in situ hybridization (FISH)-based detection of chromosomal abnormalities from patients with hematologic malignancies.
- 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.
- § 864.5430 Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients.
- § 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.
- § 864.7293 Von Willebrand factor assay.
- § 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 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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