Part 864 — Hematology and Pathology Devices
Subpart A — General Provisions
Subpart B — Biological Stains
- § 864.1850— Dye and chemical solution stains.
- § 864.1860— Immunohistochemistry reagents and kits.
- § 864.1865— Cervical intraepithelial neoplasia (CIN) test system.
- § 864.1866— Lynch syndrome test systems.
- § 864.1870— Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.
- § 864.1880— Fluorescence in situ hybridization (FISH)-based detection of chromosomal abnormalities from patients with hematologic malignancies.
Subpart C — Cell And Tissue Culture Products
- § 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.
Subpart D — Pathology Instrumentation and Accessories
- § 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.
- § 864.3700— Whole slide imaging system.
- § 864.3750— Software algorithm device to assist users in digital pathology.
- § 864.3800— Automated slide stainer.
- § 864.3875— Automated tissue processor.
Subpart E — Specimen Preparation Reagents
Subpart F — Automated and Semi-Automated Hematology Devices
- § 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.
- § 864.5430— Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients.
- § 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.
Subpart G — Manual Hematology Devices
- § 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.
Subpart H — Hematology Kits and Packages
- § 864.7010— Flow cytometric test system for hematopoietic neoplasms.
- § 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.
- § 864.7280— Factor V Leiden DNA mutation detection systems.
- § 864.7290— Factor deficiency test.
- § 864.7295— Heparin and direct oral factor Xa inhibitor drug test system.
- § 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 A<sub>2</sub> 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.
Subpart I — Hematology Reagents
- § 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.
Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products
- § 864.9050— Blood bank supplies.
- § 864.9100— Empty container for the collection and processing of blood and blood components.
- § 864.9115— Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.
- § 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.
- § 864.9165— Blood establishment computer software and accessories.
- § 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.