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e-CFR data is current as of January 21, 2021

Title 21 → Chapter I → Subchapter H → Part 864

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

rule

Subpart A—GENERAL PROVISIONS

§864.1
Scope.
§864.3
Effective dates of requirement for premarket approval.
§864.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
rule

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.
rule

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.
rule

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.
§864.3800
Automated slide stainer.
§864.3875
Automated tissue processor.
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Subpart E—SPECIMEN PREPARATION REAGENTS

§864.4010
General purpose reagent.
§864.4020
Analyte specific reagents.
§864.4400
Enzyme preparations.
rule

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.
§864.5600
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.
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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.
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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.
§864.7300
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 A2 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.
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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.
rule

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.
§864.9125
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.
rule

Subpart K—PRODUCTS USED IN ESTABLISHMENTS THAT MANUFACTURE HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS)

§864.9900
Cord blood processing system and storage container.

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