CFR /  Title 21  /  Part 864: Hematology And Pathology Devices

Section No.	Description
Section 864.1	Effective dates of requirement for premarket approval
Section 864.3	Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
Section 864.9	Dye and chemical solution stains
Section 864.1850	Immunohistochemistry reagents and kits
Section 864.1860	Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen
Section 864.1870	Synthetic cell and tissue culture media and components
Section 864.2220	Cell and tissue culture supplies and equipment
Section 864.2240	Chromosome culture kit
Section 864.2260	Cultured animal and human cells
Section 864.2280	Mycoplasma detection media and components
Section 864.2360	Animal and human sera
Section 864.2800	Balanced salt solutions or formulations
Section 864.2875	Tissue processing equipment
Section 864.3010	Specimen transport and storage container
Section 864.3250	OTC test sample collection systems for drugs of abuse testing
Section 864.3260	Cytocentrifuge
Section 864.3300	Device for sealing microsections
Section 864.3400	Microscopes and accessories
Section 864.3600	Automated slide stainer
Section 864.3800	Automated tissue processor
Section 864.3875	General purpose reagent
Section 864.4010	Analyte specific reagents
Section 864.4020	Enzyme preparations
Section 864.4400	Automated cell counter
Section 864.5200	Automated differential cell counter
Section 864.5220	Automated blood cell diluting apparatus
Section 864.5240	Automated cell-locating device
Section 864.5260	Red cell indices device
Section 864.5300	Microsedimentation centrifuge
Section 864.5350	Coagulation instrument
Section 864.5400	Multipurpose system for in vitro coagulation studies
Section 864.5425	Automated hematocrit instrument
Section 864.5600	Automated hemoglobin system
Section 864.5620	Automated heparin analyzer
Section 864.5680	Automated platelet aggregation system
Section 864.5700	Automated sedimentation rate device
Section 864.5800	Automated slide spinner
Section 864.5850	Blood volume measuring device
Section 864.5950	Bleeding time device
Section 864.6100	Capillary blood collection tube
Section 864.6150	Manual blood cell counting device
Section 864.6160	Hematocrit measuring device
Section 864.6400	Occult blood test
Section 864.6550	Osmotic fragility test
Section 864.6600	Platelet adhesion test
Section 864.6650	Platelet aggregometer
Section 864.6675	Erythrocyte sedimentation rate test
Section 864.6700	Adenosine triphosphate release assay
Section 864.7040	Antithrombin III assay
Section 864.7060	Red blood cell enzyme assay
Section 864.7100	Activated whole blood clotting time tests
Section 864.7140	Erythropoietin assay
Section 864.7250	Euglobulin lysis time tests
Section 864.7275	Factor V Leiden DNA mutation detection systems
Section 864.7280	Factor deficiency test
Section 864.7290	Fibrin monomer paracoagulation test
Section 864.7300	Fibrinogen/fibrin degradation products assay
Section 864.7320	Fibrinogen determination system
Section 864.7340	Erythrocytic glucose-6-phosphate dehydrogenase assay
Section 864.7360	Glutathione reductase assay
Section 864.7375	Hemoglobin A [bdi2] assay
Section 864.7400	Abnormal hemoglobin assay
Section 864.7415	Carboxyhemoglobin assay
Section 864.7425	Electrophoretic hemoglobin analysis system
Section 864.7440	Fetal hemoglobin assay
Section 864.7455	Glycosylated hemoglobin assay
Section 864.7470	Sulfhemoglobin assay
Section 864.7490	Whole blood hemoglobin assays
Section 864.7500	Heparin assay
Section 864.7525	Leukocyte alkaline phosphatase test
Section 864.7660	Leukocyte peroxidase test
Section 864.7675	Platelet factor 4 radioimmunoassay
Section 864.7695	Prothrombin consumption test
Section 864.7720	Prothrombin-proconvertin test and thrombotest
Section 864.7735	Prothrombin time test
Section 864.7750	Sickle cell test
Section 864.7825	Thrombin time test
Section 864.7875	Thromboplastin generation test
Section 864.7900	Partial thromboplastin time tests
Section 864.7925	Bothrops atrox reagent
Section 864.8100	Calibrator for cell indices
Section 864.8150	Calibrator for hemoglobin or hematocrit measurement
Section 864.8165	Calibrator for platelet counting
Section 864.8175	Calibrator for red cell and white cell counting
Section 864.8185	Blood cell diluent
Section 864.8200	Lymphocyte separation medium
Section 864.8500	Red cell lysing reagent
Section 864.8540	Hematology quality control mixture
Section 864.8625	Russell viper venom reagent
Section 864.8950	Blood bank supplies
Section 864.9050	Empty container for the collection and processing of blood and blood components
Section 864.9100	Vacuum-assisted blood collection system
Section 864.9125	Processing system for frozen blood
Section 864.9145	Blood group substances of nonhuman origin for in vitro diagnostic use
Section 864.9160	Automated blood grouping and antibody test system
Section 864.9175	Blood grouping view box
Section 864.9185	Blood mixing devices and blood weighing devices
Section 864.9195	Blood and plasma warming device
Section 864.9205	Cell-freezing apparatus and reagents for in vitro diagnostic use
Section 864.9225	Automated blood cell separator
Section 864.9245	Blood bank centrifuge for in vitro diagnostic use
Section 864.9275	Automated cell-washing centrifuge for immuno-hematology
Section 864.9285	Automated Coombs test systems
Section 864.9300	Copper sulfate solution for specific gravity determinations
Section 864.9320	Stabilized enzyme solution
Section 864.9400	Lectins and protectins
Section 864.9550	Environmental chamber for storage of platelet concentrate
Section 864.9575	Potentiating media for in vitro diagnostic use
Section 864.9600	Quality control kit for blood banking reagents
Section 864.9650	Blood storage refrigerator and blood storage freezer
Section 864.9700	Heat-sealing device
Section 864.9750	Transfer set
Section 864.9875	Cord blood processing system and storage container
Section 864.9900	Scope