2002 CFR Title 21, Volume 8

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
	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).
	864.1850	Dye and chemical solution stains.
	864.1860	Immunohistochemistry reagents and kits.
	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.
	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.
	864.3800	Automated slide stainer.
	864.3875	Automated tissue processor.
	864.4010	General purpose reagent.
	864.4020	Analyte specific reagents.
	864.4400	Enzyme preparations.
	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.
	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.
	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.
	864.7290	Factor deficiency test.
	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.
	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.
	864.9050	Blood bank supplies.
	864.9100	Empty container for the collection and processing of blood and blood components.
	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.
	864.9175	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.