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- 21 CFR 864.7290 · Factor deficiency test.
- 21 CFR 864.7293 · Von Willebrand factor assay.
- 21 CFR 864.7295 · Heparin and direct oral factor Xa inhibitor drug test system.
- 21 CFR 864.7300 · Fibrin monomer paracoagulation test.
- 21 CFR 864.7320 · Fibrinogen/fibrin degradation products assay.
- 21 CFR 864.7340 · Fibrinogen determination system.
- 21 CFR 864.7360 · Erythrocytic glucose-6-phosphate dehydrogenase assay.
- 21 CFR 864.7375 · Glutathione reductase assay.
- 21 CFR 864.7400 · Hemoglobin A2 assay.
- 21 CFR 864.7415 · Abnormal hemoglobin assay.
- 21 CFR 864.7425 · Carboxyhemoglobin assay.
- 21 CFR 864.7440 · Electrophoretic hemoglobin analysis system.
- 21 CFR 864.7455 · Fetal hemoglobin assay.
- 21 CFR 864.7470 · Glycosylated hemoglobin assay.
- 21 CFR 864.7490 · Sulfhemoglobin assay.
- 21 CFR 864.7500 · Whole blood hemoglobin assays.
- 21 CFR 864.7525 · Heparin assay.
- 21 CFR 864.7660 · Leukocyte alkaline phosphatase test.
- 21 CFR 864.7675 · Leukocyte peroxidase test.
- 21 CFR 864.7695 · Platelet factor 4 radioimmunoassay.
- 21 CFR 864.7720 · Prothrombin consumption test.
- 21 CFR 864.7735 · Prothrombin-proconvertin test and thrombotest.
- 21 CFR 864.7750 · Prothrombin time test.
- 21 CFR 864.7825 · Sickle cell test.
- 21 CFR 864.7875 · Thrombin time test.
- 21 CFR 864.7900 · Thromboplastin generation test.
- 21 CFR 864.7925 · Partial thromboplastin time tests.
- 21 CFR 864.8100 · Bothrops atrox reagent.
- 21 CFR 864.8150 · Calibrator for cell indices.
- 21 CFR 864.8165 · Calibrator for hemoglobin or hematocrit measurement.
- 21 CFR 864.8175 · Calibrator for platelet counting.
- 21 CFR 864.8185 · Calibrator for red cell and white cell counting.
- 21 CFR 864.8200 · Blood cell diluent.
- 21 CFR 864.8500 · Lymphocyte separation medium.
- 21 CFR 864.8540 · Red cell lysing reagent.
- 21 CFR 864.8625 · Hematology quality control mixture.
- 21 CFR 864.8950 · Russell viper venom reagent.
- 21 CFR 864.9050 · Blood bank supplies.
- 21 CFR 864.9100 · Empty container for the collection and processing of blood and blood components.
- 21 CFR 864.9115 · Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.
- 21 CFR 864.9125 · Vacuum-assisted blood collection system.
- 21 CFR 864.9145 · Processing system for frozen blood.
- 21 CFR 864.9160 · Blood group substances of nonhuman origin for in vitro diagnostic use.
- 21 CFR 864.9165 · Blood establishment computer software and accessories.
- 21 CFR 864.9175 · Automated blood grouping and antibody test system.
- 21 CFR 864.9185 · Blood grouping view box.
- 21 CFR 864.9195 · Blood mixing devices and blood weighing devices.
- 21 CFR 864.9205 · Blood and plasma warming device.
- 21 CFR 864.9225 · Cell-freezing apparatus and reagents for in vitro diagnostic use.
- 21 CFR 864.9245 · Automated blood cell separator.
- 21 CFR 864.9275 · Blood bank centrifuge for in vitro diagnostic use.
- 21 CFR 864.9285 · Automated cell-washing centrifuge for immuno-hematology.
- 21 CFR 864.9300 · Automated Coombs test systems.
- 21 CFR 864.9320 · Copper sulfate solution for specific gravity determinations.
- 21 CFR 864.9400 · Stabilized enzyme solution.
- 21 CFR 864.9550 · Lectins and protectins.
- 21 CFR 864.9575 · Environmental chamber for storage of platelet concentrate.
- 21 CFR 864.9600 · Potentiating media for in vitro diagnostic use.
- 21 CFR 864.9650 · Quality control kit for blood banking reagents.
- 21 CFR 864.9700 · Blood storage refrigerator and blood storage freezer.
- 21 CFR 864.9750 · Heat-sealing device.
- 21 CFR 864.9875 · Transfer set.
- 21 CFR 864.9900 · Cord blood processing system and storage container.
- 21 CFR 866.1 · Scope.
- 21 CFR 866.3 · Effective dates of requirement for premarket approval.
- 21 CFR 866.9 · Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- 21 CFR 866.1620 · Antimicrobial susceptibility test disc.
- 21 CFR 866.1640 · Antimicrobial susceptibility test powder.
- 21 CFR 866.1645 · Fully automated short-term incubation cycle antimicrobial susceptibility system.
- 21 CFR 866.1650 · A cellular analysis system for multiplexed antimicrobial susceptibility testing.
- 21 CFR 866.1655 · System for detection of microorganisms and antimicrobial resistance using reporter expression.
- 21 CFR 866.1700 · Culture medium for antimicrobial susceptibility tests.
- 21 CFR 866.2050 · Staphylococcal typing bacteriophage.
- 21 CFR 866.2120 · Anaerobic chamber.
- 21 CFR 866.2160 · Coagulase plasma.
- 21 CFR 866.2170 · Automated colony counter.
- 21 CFR 866.2180 · Manual colony counter.
- 21 CFR 866.2190 · Automated image assessment system for microbial colonies on solid culture media.
- 21 CFR 866.2300 · Multipurpose culture medium.
- 21 CFR 866.2320 · Differential culture medium.
- 21 CFR 866.2330 · Enriched culture medium.
- 21 CFR 866.2350 · Microbiological assay culture medium.
- 21 CFR 866.2360 · Selective culture medium.
- 21 CFR 866.2390 · Transport culture medium.
- 21 CFR 866.2410 · Culture medium for pathogenic Neisseria spp.
- 21 CFR 866.2420 · Oxidase screening test for gonorrhea.
- 21 CFR 866.2440 · Automated medium dispensing and stacking device.
- 21 CFR 866.2450 · Supplement for culture media.
- 21 CFR 866.2480 · Quality control kit for culture media.
- 21 CFR 866.2500 · Microtiter diluting and dispensing device.
- 21 CFR 866.2540 · Microbiological incubator.
- 21 CFR 866.2560 · Microbial growth monitor.
- 21 CFR 866.2580 · Gas-generating device.
- 21 CFR 866.2600 · Wood's fluorescent lamp.
- 21 CFR 866.2660 · Microorganism differentiation and identification device.
- 21 CFR 866.2680 · Streptococcus spp. nucleic acid-based assay.
- 21 CFR 866.2850 · Automated zone reader.
- 21 CFR 866.2900 · Microbiological specimen collection and transport device.
- 21 CFR 866.2950 · Microbial nucleic acid storage and stabilization device.
- 21 CFR 866.2952 · Device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples.