Home/CFR/Title 21/Part 864
FEDERAL · 21 CFR

Part 864 — Hematology and Pathology Devices

124 sections · Title 21: Food and Drugs

§ 864.1Scope.
§ 864.3Effective dates of requirement for premarket approval.
§ 864.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 864.1850Dye and chemical solution stains.
§ 864.1860Immunohistochemistry reagents and kits.
§ 864.1865Cervical intraepithelial neoplasia (CIN) test system.
§ 864.1866Lynch syndrome test systems.
§ 864.1870Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.
§ 864.1880Fluorescence in situ hybridization (FISH)-based detection of chromosomal abnormalities from patients with hematologic malignancies.
§ 864.2220Synthetic cell and tissue culture media and components.
§ 864.2240Cell and tissue culture supplies and equipment.
§ 864.2260Chromosome culture kit.
§ 864.2280Cultured animal and human cells.
§ 864.2360Mycoplasma detection media and components.
§ 864.2800Animal and human sera.
§ 864.2875Balanced salt solutions or formulations.
§ 864.3010Tissue processing equipment.
§ 864.3250Specimen transport and storage container.
§ 864.3260OTC test sample collection systems for drugs of abuse testing.
§ 864.3300Cytocentrifuge.
§ 864.3400Device for sealing microsections.
§ 864.3600Microscopes and accessories.
§ 864.3700Whole slide imaging system.
§ 864.3750Software algorithm device to assist users in digital pathology.
§ 864.3800Automated slide stainer.
§ 864.3875Automated tissue processor.
§ 864.4010General purpose reagent.
§ 864.4020Analyte specific reagents.
§ 864.4400Enzyme preparations.
§ 864.5200Automated cell counter.
§ 864.5220Automated differential cell counter.
§ 864.5240Automated blood cell diluting apparatus.
§ 864.5260Automated cell-locating device.
§ 864.5300Red cell indices device.
§ 864.5350Microsedimentation centrifuge.
§ 864.5400Coagulation instrument.
§ 864.5425Multipurpose system for in vitro coagulation studies.
§ 864.5430Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients.
§ 864.5600Automated hematocrit instrument.
§ 864.5620Automated hemoglobin system.
§ 864.5680Automated heparin analyzer.
§ 864.5700Automated platelet aggregation system.
§ 864.5800Automated sedimentation rate device.
§ 864.5850Automated slide spinner.
§ 864.5950Blood volume measuring device.
§ 864.6100Bleeding time device.
§ 864.6150Capillary blood collection tube.
§ 864.6160Manual blood cell counting device.
§ 864.6400Hematocrit measuring device.
§ 864.6550Occult blood test.
§ 864.6600Osmotic fragility test.
§ 864.6650Platelet adhesion test.
§ 864.6675Platelet aggregometer.
§ 864.6700Erythrocyte sedimentation rate test.
§ 864.7010Flow cytometric test system for hematopoietic neoplasms.
§ 864.7040Adenosine triphosphate release assay.
§ 864.7060Antithrombin III assay.
§ 864.7100Red blood cell enzyme assay.
§ 864.7140Activated whole blood clotting time tests.
§ 864.7250Erythropoietin assay.
§ 864.7275Euglobulin lysis time tests.
§ 864.7280Factor V Leiden DNA mutation detection systems.
§ 864.7290Factor deficiency test.
§ 864.7295Heparin and direct oral factor Xa inhibitor drug test system.
§ 864.7300Fibrin monomer paracoagulation test.
§ 864.7320Fibrinogen/fibrin degradation products assay.
§ 864.7340Fibrinogen determination system.
§ 864.7360Erythrocytic glucose-6-phosphate dehydrogenase assay.
§ 864.7375Glutathione reductase assay.
§ 864.7400Hemoglobin A<sub>2</sub> assay.
§ 864.7415Abnormal hemoglobin assay.
§ 864.7425Carboxyhemoglobin assay.
§ 864.7440Electrophoretic hemoglobin analysis system.
§ 864.7455Fetal hemoglobin assay.
§ 864.7470Glycosylated hemoglobin assay.
§ 864.7490Sulfhemoglobin assay.
§ 864.7500Whole blood hemoglobin assays.
§ 864.7525Heparin assay.
§ 864.7660Leukocyte alkaline phosphatase test.
§ 864.7675Leukocyte peroxidase test.
§ 864.7695Platelet factor 4 radioimmunoassay.
§ 864.7720Prothrombin consumption test.
§ 864.7735Prothrombin-proconvertin test and thrombotest.
§ 864.7750Prothrombin time test.
§ 864.7825Sickle cell test.
§ 864.7875Thrombin time test.
§ 864.7900Thromboplastin generation test.
§ 864.7925Partial thromboplastin time tests.
§ 864.8100Bothrops atrox reagent.
§ 864.8150Calibrator for cell indices.
§ 864.8165Calibrator for hemoglobin or hematocrit measurement.
§ 864.8175Calibrator for platelet counting.
§ 864.8185Calibrator for red cell and white cell counting.
§ 864.8200Blood cell diluent.
§ 864.8500Lymphocyte separation medium.
§ 864.8540Red cell lysing reagent.
§ 864.8625Hematology quality control mixture.
§ 864.8950Russell viper venom reagent.
§ 864.9050Blood bank supplies.
§ 864.9100Empty container for the collection and processing of blood and blood components.
§ 864.9115Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.
§ 864.9125Vacuum-assisted blood collection system.
§ 864.9145Processing system for frozen blood.
§ 864.9160Blood group substances of nonhuman origin for in vitro diagnostic use.
§ 864.9165Blood establishment computer software and accessories.
§ 864.9175Automated blood grouping and antibody test system.
§ 864.9185Blood grouping view box.
§ 864.9195Blood mixing devices and blood weighing devices.
§ 864.9205Blood and plasma warming device.
§ 864.9225Cell-freezing apparatus and reagents for in vitro diagnostic use.
§ 864.9245Automated blood cell separator.
§ 864.9275Blood bank centrifuge for in vitro diagnostic use.
§ 864.9285Automated cell-washing centrifuge for immuno-hematology.
§ 864.9300Automated Coombs test systems.
§ 864.9320Copper sulfate solution for specific gravity determinations.
§ 864.9400Stabilized enzyme solution.
§ 864.9550Lectins and protectins.
§ 864.9575Environmental chamber for storage of platelet concentrate.
§ 864.9600Potentiating media for in vitro diagnostic use.
§ 864.9650Quality control kit for blood banking reagents.
§ 864.9700Blood storage refrigerator and blood storage freezer.
§ 864.9750Heat-sealing device.
§ 864.9875Transfer set.
§ 864.9900Cord blood processing system and storage container.