• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-
New Search
Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 864HEMATOLOGY AND PATHOLOGY DEVICES
 

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).

Subpart B--Biological Stains
   § 864.1850 - Dye and chemical solution stains.
   § 864.1860 - Immunohistochemistry reagents and kits.

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.
   § 864.3800 - Automated slide stainer.
   § 864.3875 - Automated tissue processor.

Subpart E--Specimen Preparation Reagents
   § 864.4010 - General purpose reagent.
   § 864.4020 - Analyte specific reagents.
   § 864.4400 - Enzyme preparations.

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.

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
   § 864.7040 - 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 A2assay.
   § 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.
   § 864.9125 - 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.
   § 864.9175 - 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.

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.

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

-
-