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Part 864 - HEMATOLOGY AND PATHOLOGY DEVICES

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MEDICAL DEVICES - HEMATOLOGY AND PATHOLOGY DEVICES

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Part 864 - HEMATOLOGY AND PATHOLOGY DEVICES

Description

Official eCFR Link

§864.1 - Scope.

§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.

§864.2220 - 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.

§864.3 - Effective dates of requirement for premarket approval.

§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.

§864.3800 - 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.

§864.7010 - 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.

§864.7300 - 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 2 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.