21 C.F.R. PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
Subpart A--GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval.
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B--BIOLOGICAL STAINS
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| Dye and chemical solution stains.
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| Immunohistochemistry reagents and kits.
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Subpart C--CELL AND TISSUE CULTURE PRODUCTS
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| Synthetic cell and tissue culture media and components.
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| Cell and tissue culture supplies and equipment.
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| Cultured animal and human cells.
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| Mycoplasma detection media and components.
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| Balanced salt solutions or formulations.
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Subpart D--PATHOLOGY INSTRUMENTATION AND ACCESSORIES
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| Tissue processing equipment.
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| Specimen transport and storage container.
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| OTC test sample collection systems for drugs of abuse testing.
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| Device for sealing microsections.
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| Microscopes and accessories.
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| Automated tissue processor.
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Subpart E--SPECIMEN PREPARATION REAGENTS
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| Analyte specific reagents.
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Subpart F--AUTOMATED AND SEMI-AUTOMATED HEMATOLOGY DEVICES
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| Automated differential cell counter.
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| Automated blood cell diluting apparatus.
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| Automated cell-locating device.
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| Microsedimentation centrifuge.
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| Multipurpose system for in vitro coagulation studies.
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| Automated hematocrit instrument.
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| Automated hemoglobin system.
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| Automated heparin analyzer.
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| Automated platelet aggregation system.
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| Automated sedimentation rate device.
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| Blood volume measuring device.
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Subpart G--MANUAL HEMATOLOGY DEVICES
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| Capillary blood collection tube.
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| Manual blood cell counting device.
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| Hematocrit measuring device.
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| Erythrocyte sedimentation rate test.
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Subpart H--HEMATOLOGY KITS AND PACKAGES
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| Adenosine triphosphate release assay.
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| Red blood cell enzyme assay.
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| Activated whole blood clotting time tests.
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| Euglobulin lysis time tests.
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| Factor V Leiden DNA mutation detection systems.
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| Fibrin monomer paracoagulation test.
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| Fibrinogen/fibrin degradation products assay.
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| Fibrinogen determination system.
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| Erythrocytic glucose-6-phosphate dehydrogenase assay.
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| Glutathione reductase assay.
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| Abnormal hemoglobin assay.
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| Electrophoretic hemoglobin analysis system.
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| Glycosylated hemoglobin assay.
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| Whole blood hemoglobin assays.
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| Leukocyte alkaline phosphatase test.
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| Leukocyte peroxidase test.
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| Platelet factor 4 radioimmunoassay.
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| Prothrombin consumption test.
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| Prothrombin-proconvertin test and thrombotest.
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| Thromboplastin generation test.
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| Partial thromboplastin time tests.
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Subpart I--HEMATOLOGY REAGENTS
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| Calibrator for cell indices.
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| Calibrator for hemoglobin or hematocrit measurement.
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| Calibrator for platelet counting.
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| Calibrator for red cell and white cell counting.
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| Lymphocyte separation medium.
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| Hematology quality control mixture.
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| Russell viper venom reagent.
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Subpart J--PRODUCTS USED IN ESTABLISHMENTS THAT MANUFACTURE BLOOD AND BLOOD PRODUCTS
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| Empty container for the collection and processing of blood and blood components.
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| Vacuum-assisted blood collection system.
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| Processing system for frozen blood.
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| Blood group substances of nonhuman origin for in vitro diagnostic use.
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| Automated blood grouping and antibody test system.
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| Blood mixing devices and blood weighing devices.
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| Blood and plasma warming device.
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| Cell-freezing apparatus and reagents for in vitro diagnostic use.
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| Automated blood cell separator.
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| Blood bank centrifuge for in vitro diagnostic use.
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| Automated cell-washing centrifuge for immuno-hematology.
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| Automated Coombs test systems.
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| Copper sulfate solution for specific gravity determinations.
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| Stabilized enzyme solution.
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| Environmental chamber for storage of platelet concentrate.
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| Potentiating media for in vitro diagnostic use.
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| Quality control kit for blood banking reagents.
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| Blood storage refrigerator and blood storage freezer.
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