| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| BSA | Warmer, Blood, Electromagnetic Radiation | 第 3 类 | 21 CFR 864.9205 | |
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | 第 2 类 | 21 CFR 864.9205 | 14 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 864.7320 | 58 |
| DAR | Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 864.7340 | |
| DAT | Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 864.7340 | 2 |
| DAX | Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 864.7340 | |
| DAZ | Fibrinogen And Split Products, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 864.7340 | |
| DDQ | Antigen, Antiserum, Control, Antithrombin Iii | 第 2 类 | 21 CFR 864.7060 | 4 |
| GFK | Fibrinogen Determination Standards And Controls | 第 2 类 | 21 CFR 864.7340 | 1 |
| GFO | Activated Partial Thromboplastin | 第 2 类 | 21 CFR 864.7925 | 52 |
| GFS | Standards And Controls, Hemoglobin, Normal And Abnormal | 第 2 类 | 21 CFR 864.8625 | 1 |
| GFT | Protamine Sulphate | 第 2 类 | 21 CFR 864.7525 | 2 |
| GFX | Fibrinogen Standard | 第 2 类 | 21 CFR 864.7340 | 3 |
| GGC | Control, Plasma, Abnormal | 第 2 类 | 21 CFR 864.5425 | 40 |
| GGF | Acid Hematin | 第 2 类 | 21 CFR 864.7500 | |
| GGG | Guaiac Reagent | 第 2 类 | 21 CFR 864.6550 | 1 |
| GGH | Iron Stains | 第 1 类 | 21 CFR 864.1850 | 1 |
| GGJ | Fluid, Diluting, White-Cell | 第 1 类 | 21 CFR 864.8200 | 1 |
| GGK | Products, Red-Cell Lysing Products | 第 1 类 | 21 CFR 864.8540 | 29 |
| GGL | Control, White-Cell | 第 2 类 | 21 CFR 864.8625 | 8 |
| GGM | Control, Hemoglobin | 第 2 类 | 21 CFR 864.8625 | 15 |
| GGN | Plasma, Coagulation Control | 第 2 类 | 21 CFR 864.5425 | 99 |
| GGO | Reagent, Thromboplastin And Control | 第 2 类 | 21 CFR 864.7925 | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 第 2 类 | 21 CFR 864.7290 | 190 |
| GGQ | Test, Prothrombin Consumption | 第 2 类 | 21 CFR 864.7720 | 2 |
| GGT | Assay, Erythropoietin | 第 2 类 | 21 CFR 864.7250 | 20 |
| GGW | Test, Time, Partial Thromboplastin | 第 2 类 | 21 CFR 864.7925 | 32 |
| GGX | Pipette, Sahli | 第 1 类 | 21 CFR 864.6160 | 2 |
| GGY | Pipette, Diluting | 第 1 类 | 21 CFR 864.6160 | |
| GGZ | Oxyhemoglobin | 第 2 类 | 21 CFR 864.7500 | 2 |
| GHA | Hemoglobin, Alkali Resistant | 第 2 类 | 21 CFR 864.7455 | |
| GHC | Tube, Sedimentation Rate | 第 1 类 | 21 CFR 864.6700 | 1 |
| GHD | Test, Leukocyte Alkaline Phosphatase | 第 1 类 | 21 CFR 864.7660 | 4 |
| GHH | Fibrin Split Products | 第 2 类 | 21 CFR 864.7320 | 28 |
| GHK | Centrifuge, Microsedimentation | 第 1 类 | 21 CFR 864.5350 | |
| GHM | Test, Sickle Cell | 第 2 类 | 21 CFR 864.7825 | 18 |
| GHO | Hemocytometer | 第 1 类 | 21 CFR 864.6160 | 2 |
| GHQ | Stain, Fetal Hemoglobin | 第 2 类 | 21 CFR 864.7455 | 2 |
| GHR | Reagent, Platelet Aggregation | 第 2 类 | 21 CFR 864.5700 | 11 |
| GHS | Assay, Carboxyhemoglobin | 第 2 类 | 21 CFR 864.7425 | 5 |
| GHY | Hematocrit, Tube, Rack, Sealer, Holder | 第 2 类 | 21 CFR 864.6400 | 2 |
| GHZ | Solution, Gugol Blue | 第 1 类 | 21 CFR 864.1850 | |
| GIA | Test, Leukocyte Peroxidase | 第 1 类 | 21 CFR 864.7675 | 3 |
| GIE | Fibrometer | 第 2 类 | 21 CFR 864.5400 | 2 |
| GIF | Diluent, Blood Cell | 第 1 类 | 21 CFR 864.8200 | 38 |
| GIG | Hemoglobinometer | 第 2 类 | 21 CFR 864.7500 | 3 |
| GII | Glutathione, Red-Cell | 第 2 类 | 21 CFR 864.7375 | |
| GIL | Plasma, Fibrinogen Control | 第 2 类 | 21 CFR 864.7340 | 8 |
| GIO | Tube, Collection, Capillary Blood | 第 1 类 | 21 CFR 864.6150 | 22 |
| GIQ | Hemoglobin S | 第 2 类 | 21 CFR 864.7415 | 3 |
| GIR | Reagent, Russel Viper Venom | 第 1 类 | 21 CFR 864.8950 | 16 |
| GIS | Test, Fibrinogen | 第 2 类 | 21 CFR 864.7340 | 13 |
| GIT | Reagent & Control, Partial Thromboplastin Time | 第 2 类 | 21 CFR 864.7925 | 4 |
| GIZ | Plasma, Control, Normal | 第 2 类 | 21 CFR 864.5425 | 20 |
| GJA | Test, Thrombin Time | 第 2 类 | 21 CFR 864.7875 | 20 |
| GJB | Thrombin | 第 2 类 | 21 CFR 864.7875 | 1 |
| GJC | Assay, Sulfhemoglobin | 第 2 类 | 21 CFR 864.7490 | |
| GJG | Pipette, Quantitative, Hematology | 第 1 类 | 21 CFR 864.6160 | 4 |
| GJH | Stain, Reticulocyte | 第 1 类 | 21 CFR 864.1850 | 1 |
| GJJ | Stains, Heinz Body | 第 1 类 | 21 CFR 864.1850 | |
| GJL | Romanowsky Stains | 第 1 类 | 21 CFR 864.1850 | 1 |
| GJN | Fluid, Diluting, Red-Cell | 第 1 类 | 21 CFR 864.8200 | |
| GJP | Control, Platelet | 第 2 类 | 21 CFR 864.8625 | 4 |
| GJR | Control, Red-Cell | 第 2 类 | 21 CFR 864.8625 | 5 |
| GJS | Test, Time, Prothrombin | 第 2 类 | 21 CFR 864.7750 | 127 |
| GJT | Plasma, Coagulation Factor Deficient | 第 2 类 | 21 CFR 864.7290 | 79 |
| GJW | Pipette, Pasteur | 第 1 类 | 21 CFR 864.6160 | 4 |
| GJZ | Cyanomethemoglobin Reagent And Standard Solution | 第 2 类 | 21 CFR 864.7500 | 2 |
| GKA | Abnormal Hemoglobin Quantitation | 第 2 类 | 21 CFR 864.7415 | 23 |
| GKB | Device, Automated Sedimentation Rate | 第 1 类 | 21 CFR 864.5800 | 2 |
| GKE | Osmotic Fragility Testing | 第 1 类 | 21 CFR 864.6600 | |
| GKF | Instrument, Hematocrit, Automated | 第 2 类 | 21 CFR 864.5600 | 15 |
| GKG | Centrifuge, Hematocrit | 第 2 类 | 21 CFR 864.6400 | 11 |
| GKH | Apparatus, Automated Blood Cell Diluting | 第 1 类 | 21 CFR 864.5240 | 14 |
| GKJ | Spinner, Slide, Automated | 第 1 类 | 21 CFR 864.5850 | 6 |
| GKK | Cyanomethemoglobin | 第 2 类 | 21 CFR 864.7500 | 7 |
| GKL | Counter, Cell, Automated (Particle Counter) | 第 2 类 | 21 CFR 864.5200 | 130 |
| GKM | Hand-Tally, Differential | 第 1 类 | 21 CFR 864.6160 | 4 |
| GKN | Timer, Clot, Automated | 第 2 类 | 21 CFR 864.5400 | 3 |
| GKP | Instrument, Coagulation, Automated | 第 2 类 | 21 CFR 864.5400 | 49 |
| GKQ | Test, Thromboplastin Generation | 第 1 类 | 21 CFR 864.7900 | 1 |
| GKR | System, Hemoglobin, Automated | 第 2 类 | 21 CFR 864.5620 | 39 |
| GKT | Separator, Automated, Blood Cell, Diagnostic | 第 2 类 | 21 CFR 864.9245 | 10 |
| GKW | Aggregometer, Platelet, Thrombokinetogram | 第 2 类 | 21 CFR 864.6675 | |
| GKX | Instrument, Automated Platelet Counting | 第 2 类 | 21 CFR 864.5200 | 2 |
| GKZ | Counter, Differential Cell | 第 2 类 | 21 CFR 864.5220 | 380 |
| GLG | Platelet Counting, Manual | 第 1 类 | 21 CFR 864.6160 | 3 |
| GLK | Control, Hematocrit | 第 2 类 | 21 CFR 864.8625 | 7 |
| GLQ | Mixture, Control, White-Cell And Red-Cell Indices | 第 2 类 | 21 CFR 864.8625 | 10 |
| GLY | Oximeter To Measure Hemoglobin | 第 2 类 | 21 CFR 864.7500 | 5 |
| HYB | Eosin Y | 第 1 类 | 21 CFR 864.1850 | 10 |
| HYC | Fast Green | 第 1 类 | 21 CFR 864.1850 | 1 |
| HYD | Fast Red Salt B | 第 1 类 | 21 CFR 864.1850 | 1 |
| HYE | Solution, Fontanna Silver | 第 1 类 | 21 CFR 864.1850 | |
| HYF | Giemsa Stain | 第 1 类 | 21 CFR 864.1850 | 4 |
| HYG | Glenner'S Stain | 第 1 类 | 21 CFR 864.1850 | 1 |
| HYH | Gold Chloride | 第 1 类 | 21 CFR 864.1850 | |
| HYI | Iodine, Grams | 第 1 类 | 21 CFR 864.1850 | 6 |
| HYJ | Hematoxylin | 第 1 类 | 21 CFR 864.1850 | 14 |
| HYK | Hematoxylin Harris'S | 第 1 类 | 21 CFR 864.1850 | 7 |
| HYL | Hematoxylin Mayer'S | 第 1 类 | 21 CFR 864.1850 | |
| HYO | Hematoxylin Weigert'S | 第 1 类 | 21 CFR 864.1850 | 1 |
| HYQ | Iron Chloride-Weigert | 第 1 类 | 21 CFR 864.1850 | |
| HYR | Leuco-Patent Blue | 第 1 类 | 21 CFR 864.1850 | |
| HYS | Light Green | 第 1 类 | 21 CFR 864.1850 | 1 |
| HYT | Luxol Fast Blue | 第 1 类 | 21 CFR 864.1850 | |
| HYW | Stain, Trichrome, Mallory'S | 第 1 类 | 21 CFR 864.1850 | 2 |
| HYY | Metanil Yellow | 第 1 类 | 21 CFR 864.1850 | |
| HYZ | Methenamine Silver | 第 1 类 | 21 CFR 864.1850 | |
| HZA | Methyl Green | 第 1 类 | 21 CFR 864.1850 | 2 |
| HZC | Mucicarmine | 第 1 类 | 21 CFR 864.1850 | 2 |
| HZD | Muller'S Colloidal Iron | 第 1 类 | 21 CFR 864.1850 | |
| HZE | Nile Blue | 第 1 类 | 21 CFR 864.1850 | |
| HZF | Nuclear Fast Red | 第 1 类 | 21 CFR 864.1850 | |
| HZG | Oil Red O | 第 1 类 | 21 CFR 864.1850 | 1 |
| HZH | Orange G | 第 1 类 | 21 CFR 864.1850 | 4 |
| HZJ | Stain, Papanicolau | 第 1 类 | 21 CFR 864.1850 | 15 |
| HZL | Phloxine B | 第 1 类 | 21 CFR 864.1850 | 1 |
| HZM | Hematoxylin, Acid, Phosphotungstic | 第 1 类 | 21 CFR 864.1850 | |
| HZN | Picro Methyl Blue | 第 1 类 | 21 CFR 864.1850 | |
| HZO | Stain, Ponceau | 第 1 类 | 21 CFR 864.1850 | 1 |
| HZP | Pyronin | 第 1 类 | 21 CFR 864.1850 | |
| HZQ | Red-Violet Lb | 第 1 类 | 21 CFR 864.1850 | |
| HZR | Resorcin Fuchsin | 第 1 类 | 21 CFR 864.1850 | |
| HZS | Safranin | 第 1 类 | 21 CFR 864.1850 | 1 |
| HZT | Reagent, Schiff | 第 1 类 | 21 CFR 864.1850 | 5 |
| HZX | Silver Nitrate | 第 1 类 | 21 CFR 864.1850 | |
| HZY | Sirius Red | 第 1 类 | 21 CFR 864.1850 | |
| HZZ | Sudan Black B | 第 1 类 | 21 CFR 864.1850 | 2 |
| IAA | Titan Yellow | 第 1 类 | 21 CFR 864.1850 | |
| IAB | Toluidine Blue | 第 1 类 | 21 CFR 864.1850 | 1 |
| IAC | Van Gieson'S Stain | 第 1 类 | 21 CFR 864.1850 | 1 |
| IAD | Van Gieson'S Picro-Fuchsin | 第 1 类 | 21 CFR 864.1850 | |
| IAE | Hematoxylin, Iron, Weigert'S | 第 1 类 | 21 CFR 864.1850 | 1 |
| IAF | Wright'S Stain | 第 1 类 | 21 CFR 864.1850 | 33 |
| ICC | Eosin B | 第 1 类 | 21 CFR 864.1850 | 1 |
| ICD | Darrow Red | 第 1 类 | 21 CFR 864.1850 | |
| ICF | Crystal Violet For Histology | 第 1 类 | 21 CFR 864.1850 | 5 |
| ICG | Cresyl Violet Acetate | 第 1 类 | 21 CFR 864.1850 | |
| ICH | Congo Red | 第 1 类 | 21 CFR 864.1850 | 1 |
| ICI | Hematoxylin, Chrome Alum | 第 1 类 | 21 CFR 864.1850 | |
| ICJ | Carbol Night Blue | 第 1 类 | 21 CFR 864.1850 | 1 |
| ICL | Carbol Fuchsin | 第 1 类 | 21 CFR 864.1850 | 4 |
| ICM | Brilliant Yellow | 第 1 类 | 21 CFR 864.1850 | |
| ICN | Biebrich Scarlet | 第 1 类 | 21 CFR 864.1850 | 2 |
| ICO | Best'S Carmine | 第 1 类 | 21 CFR 864.1850 | |
| ICQ | Azure A | 第 1 类 | 21 CFR 864.1850 | |
| ICR | Azocarmine B | 第 1 类 | 21 CFR 864.1850 | |
| ICS | Azocarmine G | 第 1 类 | 21 CFR 864.1850 | |
| ICT | Azan Counterstain | 第 1 类 | 21 CFR 864.1850 | |
| ICX | Aniline | 第 1 类 | 21 CFR 864.1850 | 1 |
| ICY | Acid, Aniline, Fuchsin | 第 1 类 | 21 CFR 864.1850 | |
| ICZ | Ammoniacal Silver Hydroxide Silver Nitrate | 第 1 类 | 21 CFR 864.1850 | |
| IDA | Alcian Blue | 第 1 类 | 21 CFR 864.1850 | 2 |
| IDB | Aldehyde Fuchsin | 第 1 类 | 21 CFR 864.1850 | |
| IDC | Acridine Orange | 第 1 类 | 21 CFR 864.1850 | 4 |
| IDD | Alizarin Red | 第 1 类 | 21 CFR 864.1850 | |
| IDE | Acid, Hematein | 第 1 类 | 21 CFR 864.1850 | |
| IDF | Acid, Fuchsin | 第 1 类 | 21 CFR 864.1850 | 1 |
| JBB | Solubility, Hemoglobin, Abnormal | 第 2 类 | 21 CFR 864.7825 | 2 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 第 2 类 | 21 CFR 864.7440 | 26 |
| JBE | Cell Enzymes (Erythrocytic And Leukocytic) | 第 2 类 | 21 CFR 864.7100 | 1 |
| JBF | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | 第 2 类 | 21 CFR 864.7360 | 5 |
| JBG | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot | 第 2 类 | 21 CFR 864.7360 | |
| JBH | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod | 第 2 类 | 21 CFR 864.7360 | |
| JBI | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition | 第 2 类 | 21 CFR 864.7360 | |
| JBJ | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduct | 第 2 类 | 21 CFR 864.7360 | |
| JBK | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic | 第 2 类 | 21 CFR 864.7360 | |
| JBL | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative | 第 2 类 | 21 CFR 864.7360 | 2 |
| JBM | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis | 第 2 类 | 21 CFR 864.7360 | |
| JBN | Fibrin Monomer Paracoagulation | 第 2 类 | 21 CFR 864.7300 | 2 |
| JBO | Test, Euglobulin Lysis | 第 2 类 | 21 CFR 864.7275 | 1 |
| JBP | Activated Whole Blood Clotting Time | 第 2 类 | 21 CFR 864.7140 | 24 |
| JBQ | Antithrombin Iii Quantitation | 第 2 类 | 21 CFR 864.7060 | 56 |
| JBR | Test, Heparin Neutralization | 第 2 类 | 21 CFR 864.7525 | 3 |
| JBT | Timer, Coagulation | 第 2 类 | 21 CFR 864.5400 | |
| JBW | Red-Cell Indices, Measured | 第 2 类 | 21 CFR 864.5300 | |
| JBX | Aggregrometer, Platelet | 第 2 类 | 21 CFR 864.6675 | 12 |
| JBY | Aggregometer, Platelet, Photo-Optical Scanning | 第 2 类 | 21 CFR 864.6675 | 2 |
| JBZ | Study, Platelet Adhesive | 第 2 类 | 21 CFR 864.6650 | 3 |
| JCA | Device, Bleeding Time | 第 2 类 | 21 CFR 864.6100 | 7 |
| JCF | Lymphocyte Separation Medium | 第 1 类 | 21 CFR 864.8500 | 12 |
| JCG | Fluid, Diluting, Manual Cell | 第 1 类 | 21 CFR 864.8200 | 1 |
| JCH | Esterase | 第 1 类 | 21 CFR 864.1850 | |
| JCI | Acid Phosphatase, Cytochemical | 第 1 类 | 21 CFR 864.1850 | |
| JCJ | Alkaline Phosphatase | 第 1 类 | 21 CFR 864.7660 | |
| JCM | Control, Hemoglobin, Abnormal | 第 2 类 | 21 CFR 864.7415 | 12 |
| JCN | Control, Cell Counter, Normal And Abnormal | 第 2 类 | 21 CFR 864.8625 | 12 |
| JCO | Bothrops Atrox Reagent | 第 2 类 | 21 CFR 864.8100 | 7 |
| JIO | Blood, Occult, Colorimetric, In Urine | 第 2 类 | 21 CFR 864.6550 | 11 |
| JIP | Blood, Occult, Enzymatic Method, In Urine | 第 2 类 | 21 CFR 864.6550 | |
| JLM | Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase | 第 2 类 | 21 CFR 864.7360 | 1 |
| JMB | Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase | 第 2 类 | 21 CFR 864.7360 | 1 |
| JMC | Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase | 第 2 类 | 21 CFR 864.7360 | |
| JMH | Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase | 第 2 类 | 21 CFR 864.7375 | |
| JOX | Analyzer, Heparin, Automated | 第 2 类 | 21 CFR 864.5680 | 15 |
| JOY | Device, Automated Cell-Locating | 第 2 类 | 21 CFR 864.5260 | 35 |
| JOZ | System, Automated Platelet Aggregation | 第 2 类 | 21 CFR 864.5700 | 38 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 第 2 类 | 21 CFR 864.5425 | 181 |
| JPB | Hemoglobin M | 第 2 类 | 21 CFR 864.7415 | |