FDA medical devices classification list

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

    - Scope.
    - Effective dates of requirement for premarket approval.

    - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    - Dye and chemical solution stains.
    - Immunohistochemistry reagents and kits.
    - Cervical intraepithelial neoplasia (CIN) test system.
    - Lynch syndrome test systems.
    - Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.

    - Synthetic cell and tissue culture media and components.
    - Cell and tissue culture supplies and equipment.
    - Chromosome culture kit.
    - Cultured animal and human cells.
    - Mycoplasma detection media and components.
    - Animal and human sera.
    - Balanced salt solutions or formulations.

    - Tissue processing equipment.
    - Specimen transport and storage container.
    - OTC test sample collection systems for drugs of abuse testing.
    - Cytocentrifuge.
    - Device for sealing microsections.
    - Microscopes and accessories.
    - Whole slide imaging system.
    - Automated slide stainer.
    - Automated tissue processor.

    - General purpose reagent.
    - Analyte specific reagents.
    - Enzyme preparations.

    - Automated cell counter.
    - Automated differential cell counter.
    - Automated blood cell diluting apparatus.
    - Automated cell-locating device.
    - Red cell indices device.
    - Microsedimentation centrifuge.
    - Coagulation instrument.
    - Multipurpose system for in vitro coagulation studies.
    - Automated hematocrit instrument.
    - Automated hemoglobin system.

    - Automated heparin analyzer.
    - Automated platelet aggregation system.
    - Automated sedimentation rate device.
    - Automated slide spinner.
    - Blood volume measuring device.

    - Bleeding time device.
    - Capillary blood collection tube.
    - Manual blood cell counting device.
    - Hematocrit measuring device.
    - Occult blood test.
    - Osmotic fragility test.
    - Platelet adhesion test.
    - Platelet aggregometer.
    - Erythrocyte sedimentation rate test.

    - Flow cytometric test system for hematopoietic neoplasms.
    - Adenosine triphosphate release assay.
    - Antithrombin III assay.
    - Red blood cell enzyme assay.
    - Activated whole blood clotting time tests.
    - Erythropoietin assay.
    - Euglobulin lysis time tests.
    - Factor V Leiden DNA mutation detection systems.
    - Factor deficiency test.
    - Fibrin monomer paracoagulation test.
    - Fibrinogen/fibrin degradation products assay.
    - Fibrinogen determination system.
    - Erythrocytic glucose-6-phosphate dehydrogenase assay.
    - Glutathione reductase assay.
    - Hemoglobin A2 assay.
    - Abnormal hemoglobin assay.
    - Carboxyhemoglobin assay.
    - Electrophoretic hemoglobin analysis system.
    - Fetal hemoglobin assay.
    - Glycosylated hemoglobin assay.
    - Sulfhemoglobin assay.
    - Whole blood hemoglobin assays.
    - Heparin assay.
    - Leukocyte alkaline phosphatase test.
    - Leukocyte peroxidase test.
    - Platelet factor 4 radioimmunoassay.
    - Prothrombin consumption test.

    - Prothrombin-proconvertin test and thrombotest.
    - Prothrombin time test.
    - Sickle cell test.
    - Thrombin time test.
    - Thromboplastin generation test.
    - Partial thromboplastin time tests.

    - Bothrops atrox reagent.
    - Calibrator for cell indices.
    - Calibrator for hemoglobin or hematocrit measurement.
    - Calibrator for platelet counting.
    - Calibrator for red cell and white cell counting.
    - Blood cell diluent.
    - Lymphocyte separation medium.
    - Red cell lysing reagent.
    - Hematology quality control mixture.
    - Russell viper venom reagent.

    - Blood bank supplies.
    - Empty container for the collection and processing of blood and blood components.
    - Vacuum-assisted blood collection system.
    - Processing system for frozen blood.
    - Blood group substances of nonhuman origin for in vitro diagnostic use.
    - Blood establishment computer software and accessories.
    - Automated blood grouping and antibody test system.
    - Blood grouping view box.
    - Blood mixing devices and blood weighing devices.
    - Blood and plasma warming device.
    - Cell-freezing apparatus and reagents for in vitro diagnostic use.
    - Automated blood cell separator.
    - Blood bank centrifuge for in vitro diagnostic use.
    - Automated cell-washing centrifuge for immuno-hematology.
    - Automated Coombs test systems.
    - Copper sulfate solution for specific gravity determinations.
    - Stabilized enzyme solution.
    - Lectins and protectins.
    - Environmental chamber for storage of platelet concentrate.
    - Potentiating media for in vitro diagnostic use.
    - Quality control kit for blood banking reagents.
    - Blood storage refrigerator and blood storage freezer.
    - Heat-sealing device.
    - Transfer set.

    - Cord blood processing system and storage container.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

Extracted from US.FDA.