e-CFR data is current as of February 20, 2020
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) 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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| Cervical intraepithelial neoplasia (CIN) test system. |
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| Lynch syndrome test systems. |
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| Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization. |
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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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| Whole slide imaging system. |
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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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| Flow cytometric test system for hematopoietic neoplasms. |
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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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| Blood establishment computer software and accessories. |
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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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Subpart K—PRODUCTS USED IN ESTABLISHMENTS THAT MANUFACTURE HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS)
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| Cord blood processing system and storage container. |
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