标题 21--食品和药品
第一章--食品和药物管理局
卫生与公众服务
部 分章 H 分章 - 医疗器械
第864部分 血液学和病理学设备
PART 864 | HEMATOLOGY AND PATHOLOGY DEVICES |
Subpart A - General Provisions
§ 864.1 - Scope.
§ 864.3 - Effective dates of requirement forpremarket approval.
§ 864.9 - Limitations of exemptions fromsection 510(k) of the Federal Food, Drug, and Cosmetic Act (theact).
Subpart B - Biological Stains
§ 864.1850 - Dye and chemical solutionstains.
§ 864.1860 - Immunohistochemistry reagentsand kits.
§ 864.1865 - Cervical intraepithelialneoplasia (CIN) test system.
§ 864.1866 - Lynch syndrome testsystems.
§ 864.1870 - Early growth response 1 (EGR1)gene fluorescence in-situ hybridization (FISH) test system forspecimen characterization.
Subpart C - Cell And Tissue CultureProducts
§ 864.2220 - Synthetic cell and tissueculture media and components.
§ 864.2240 - Cell and tissue culturesupplies and equipment.
§ 864.2260 - Chromosome culture kit.
§ 864.2280 - Cultured animal and humancells.
§ 864.2360 - Mycoplasma detection media andcomponents.
§ 864.2800 - Animal and human sera.
§ 864.2875 - Balanced salt solutions orformulations.
Subpart D - Pathology Instrumentation andAccessories
§ 864.3010 - Tissue processingequipment.
§ 864.3250 - Specimen transport and storagecontainer.
§ 864.3260 - OTC test sample collectionsystems for drugs of abuse testing.
§ 864.3300 - Cytocentrifuge.
§ 864.3400 - Device for sealingmicrosections.
§ 864.3600 - Microscopes andaccessories.
§ 864.3700 - Whole slide imaging system.
§ 864.3750 - Software algorithm device toassist 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 HematologyDevices
§ 864.5200 - Automated cell counter.
§ 864.5220 - Automated differential cellcounter.
§ 864.5240 - Automated blood cell dilutingapparatus.
§ 864.5260 - Automated cell-locatingdevice.
§ 864.5300 - Red cell indices device.
§ 864.5350 - Microsedimentationcentrifuge.
§ 864.5400 - Coagulation instrument.
§ 864.5425 - Multipurpose system for invitro coagulation studies.
§ 864.5600 - Automated hematocritinstrument.
§ 864.5620 - Automated hemoglobinsystem.
§ 864.5680 - Automated heparin analyzer.
§ 864.5700 - Automated platelet aggregationsystem.
§ 864.5800 - Automated sedimentation ratedevice.
§ 864.5850 - Automated slide spinner.
§ 864.5950 - Blood volume measuringdevice.
Subpart G - Manual Hematology Devices
§ 864.6100 - Bleeding time device.
§ 864.6150 - Capillary blood collectiontube.
§ 864.6160 - Manual blood cell countingdevice.
§ 864.6400 - Hematocrit measuringdevice.
§ 864.6550 - Occult blood test.
§ 864.6600 - Osmotic fragility test.
§ 864.6650 - Platelet adhesion test.
§ 864.6675 - Platelet aggregometer.
§ 864.6700 - Erythrocyte sedimentation ratetest.
Subpart H - Hematology Kits and Packages
§ 864.7010 - Flow cytometric test system forhematopoietic neoplasms.
§ 864.7040 - Adenosine triphosphate releaseassay.
§ 864.7060 - Antithrombin III assay.
§ 864.7100 - Red blood cell enzymeassay.
§ 864.7140 - Activated whole blood clottingtime tests.
§ 864.7250 - Erythropoietin assay.
§ 864.7275 - Euglobulin lysis timetests.
§ 864.7280 - Factor V Leiden DNA mutationdetection systems.
§ 864.7290 - Factor deficiency test.
§ 864.7300 - Fibrin monomer paracoagulationtest.
§ 864.7320 - Fibrinogen/fibrin degradationproducts assay.
§ 864.7340 - Fibrinogen determinationsystem.
§ 864.7360 - Erythrocyticglucose-6-phosphate dehydrogenase assay.
§ 864.7375 - Glutathione reductaseassay.
§ 864.7400 - Hemoglobin A2 assay.
§ 864.7415 - Abnormal hemoglobin assay.
§ 864.7425 - Carboxyhemoglobin assay.
§ 864.7440 - Electrophoretic hemoglobinanalysis system.
§ 864.7455 - Fetal hemoglobin assay.
§ 864.7470 - Glycosylated hemoglobinassay.
§ 864.7490 - Sulfhemoglobin assay.
§ 864.7500 - Whole blood hemoglobinassays.
§ 864.7525 - Heparin assay.
§ 864.7660 - Leukocyte alkaline phosphatasetest.
§ 864.7675 - Leukocyte peroxidase test.
§ 864.7695 - Platelet factor 4radioimmunoassay.
§ 864.7720 - Prothrombin consumptiontest.
§ 864.7735 - Prothrombin-proconvertin testand thrombotest.
§ 864.7750 - Prothrombin time test.
§ 864.7825 - Sickle cell test.
§ 864.7875 - Thrombin time test.
§ 864.7900 - Thromboplastin generationtest.
§ 864.7925 - Partial thromboplastin timetests.
Subpart I - Hematology Reagents
§ 864.8100 - Bothrops atrox reagent.
§ 864.8150 - Calibrator for cellindices.
§ 864.8165 - Calibrator for hemoglobin orhematocrit measurement.
§ 864.8175 - Calibrator for plateletcounting.
§ 864.8185 - Calibrator for red cell andwhite cell counting.
§ 864.8200 - Blood cell diluent.
§ 864.8500 - Lymphocyte separationmedium.
§ 864.8540 - Red cell lysing reagent.
§ 864.8625 - Hematology quality controlmixture.
§ 864.8950 - Russell viper venomreagent.
Subpart J - Products Used In Establishments ThatManufacture Blood and Blood Products
§ 864.9050 - Blood bank supplies.
§ 864.9100 - Empty container for thecollection and processing of blood and blood components.
§ 864.9115 - Container system for theprocessing and storage of Red Blood Cell components under reducedoxygen conditions.
§ 864.9125 - Vacuum-assisted bloodcollection system.
§ 864.9145 - Processing system for frozenblood.
§ 864.9160 - Blood group substances ofnonhuman origin for in vitro diagnostic use.
§ 864.9165 - Blood establishment computersoftware and accessories.
§ 864.9175 - Automated blood grouping andantibody test system.
§ 864.9185 - Blood grouping view box.
§ 864.9195 - Blood mixing devices and bloodweighing devices.
§ 864.9205 - Blood and plasma warmingdevice.
§ 864.9225 - Cell-freezing apparatus andreagents for in vitro diagnostic use.
§ 864.9245 - Automated blood cellseparator.
§ 864.9275 - Blood bank centrifuge for invitro diagnostic use.
§ 864.9285 - Automated cell-washingcentrifuge for immuno-hematology.
§ 864.9300 - Automated Coombs testsystems.
§ 864.9320 - Copper sulfate solution forspecific gravity determinations.
§ 864.9400 - Stabilized enzyme solution.
§ 864.9550 - Lectins and protectins.
§ 864.9575 - Environmental chamber forstorage of platelet concentrate.
§ 864.9600 - Potentiating media for in vitrodiagnostic use.
§ 864.9650 - Quality control kit for bloodbanking reagents.
§ 864.9700 - Blood storage refrigerator andblood storage freezer.
§ 864.9750 - Heat-sealing device.
§ 864.9875 - Transfer set.
Subpart K - Products Used In Establishments ThatManufacture Human Cells, Tissues, and Cellular and Tissue-BasedProducts (HCT/Ps)
§ 864.9900 - Cord blood processing systemand storage container.
