| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 第 2 类 | 21 CFR 866.5510 | 29 |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 第 2 类 | 21 CFR 866.5510 | 61 |
| CFQ | Radioimmunoassay, Immunoglobulins (G, A, M) | 第 2 类 | 21 CFR 866.5510 | 12 |
| CGM | Method, Immunodiffusion, Immunoglobulins (G, A, M) | 第 2 类 | 21 CFR 866.5510 | 4 |
| CHN | Immunochemical, Ceruloplasmin | 第 2 类 | 21 CFR 866.5210 | 3 |
| CZJ | Igd, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 8 |
| CZK | Iga, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 1 |
| CZL | Iga, Peroxidase, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | |
| CZM | Iga, Ferritin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 1 |
| CZN | Iga, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 7 |
| CZO | Inter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5890 | |
| CZP | Iga, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 54 |
| CZQ | Bence-Jones Protein, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5150 | 2 |
| CZR | Hemopexin, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5490 | |
| CZS | Retinol-Binding Protein, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5765 | 3 |
| CZT | Hemopexin, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5490 | |
| CZW | Complement C3, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5240 | 44 |
| CZX | Hemopexin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5490 | 3 |
| CZY | Complement C1s, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5240 | 1 |
| CZZ | Haptoglobin, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5460 | |
| DAA | Igg, Peroxidase, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 5 |
| DAB | Haptoglobin, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5460 | 3 |
| DAC | Complement C3b Activator, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5260 | 2 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5460 | 18 |
| DAE | Complement C9, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5240 | 6 |
| DAF | Gamma Globulin, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 1 |
| DAG | Complement C8, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5240 | |
| DAH | Gamma Globulin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 7 |
| DAI | Complement C1r, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5240 | |
| DAJ | Free Secretory Component, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5380 | |
| DAK | Complement C1q, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5240 | 28 |
| DAL | Fraction Iv-5, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5360 | |
| DAM | Hemoglobin, Chain Specific, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5470 | |
| DAN | Fibrinopeptide A, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5350 | 3 |
| DAO | Igm (Mu Chain Specific), Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | 8 |
| DAQ | Igg (Fd Fragment Specific), Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5540 | 1 |
| DAS | Igg (Fc Fragment Specific), Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5530 | 8 |
| DAW | Alpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5425 | |
| DAY | Complement C5, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5240 | 3 |
| DBA | Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5250 | 13 |
| DBC | Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5425 | |
| DBE | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Contr | 第 2 类 | 21 CFR 866.5120 | 6 |
| DBF | Ferritin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5340 | 87 |
| DBH | Fc, Rhodamine, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5530 | |
| DBI | Complement C4, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5240 | 34 |
| DBJ | Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control | 第 2 类 | 21 CFR 866.5110 | 2 |
| DBK | Fc, Fitc, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5530 | |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 第 2 类 | 21 CFR 866.5660 | 24 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Contr | 第 2 类 | 21 CFR 866.5090 | 27 |
| DBN | Fc, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5530 | 1 |
| DBT | Factor Xiii A, S, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5330 | 1 |
| DBY | Fab, Rhodamine, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5520 | 6 |
| DCB | Fab, Fitc, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5520 | 1 |
| DCE | Fab, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5520 | 2 |
| DCF | Albumin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5040 | 37 |
| DCH | System, Test, C-Reactive Protein, Rhodamine | 第 2 类 | 21 CFR 866.5270 | 1 |
| DCJ | Beta-Globulin, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5160 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 第 2 类 | 21 CFR 866.5270 | 126 |
| DCN | System, Test, C-Reactive Protein | 第 2 类 | 21 CFR 866.5270 | 70 |
| DCO | Alpha-Globulin, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5400 | |
| DCT | Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5210 | |
| DCY | Ceruloplasmin, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5210 | |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5210 | 19 |
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5870 | 13 |
| DDD | Transferrin, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5880 | 1 |
| DDE | Carbonic Anhydrase C, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5200 | 3 |
| DDF | Prothrombin, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5735 | 2 |
| DDG | Transferrin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5880 | 48 |
| DDH | Carbonic Anhydrase B, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5200 | |
| DDI | Transferrin, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5880 | 2 |
| DDJ | Thyroglobulin, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5870 | |
| DDK | Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5440 | |
| DDL | Thyroglobulin, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5870 | |
| DDN | Beta-2-Glycoprotein I, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5430 | |
| DDO | Myoglobin, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5680 | |
| DDR | Myoglobin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5680 | 46 |
| DDS | Prealbumin, Fitc, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5060 | 4 |
| DDT | Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5620 | |
| DDX | Plasminogen, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5715 | 10 |
| DDY | Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5620 | 1 |
| DDZ | Albumin, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5040 | 4 |
| DEA | Myoglobin, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5680 | |
| DEB | Alpha-2-Macroglobulin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5620 | 13 |
| DEC | Inter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5890 | |
| DEF | Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5425 | 1 |
| DEG | Lactoferrin, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5570 | 8 |
| DEH | Lambda, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | 53 |
| DEI | Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5130 | 2 |
| DEJ | Alpha-2-Glycoproteins, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5425 | |
| DEK | Kappa, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | |
| DEL | Lipoprotein X, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5590 | 5 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5130 | 30 |
| DEN | Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5420 | 2 |
| DEO | Kappa, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | 2 |
| DEP | Lambda, Peroxidase, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | 1 |
| DER | Alpha-1-Lipoprotein, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5580 | 17 |
| DES | Lambda, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | 2 |
| DET | Lactic Dehydrogenase, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5560 | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 76 |
| DEX | Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5420 | 5 |
| DEY | Igm, Peroxidase, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | 3 |
| DEZ | Igm, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | |
| DFB | Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5130 | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5600 | 43 |
| DFD | Kappa, Peroxidase, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | 3 |
| DFF | Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5080 | 1 |
| DFG | Lambda, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | 1 |
| DFH | Kappa, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | 63 |
| DFI | Total Spinal-Fluid, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5860 | 4 |
| DFJ | Albumin, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5040 | |
| DFK | Igg (Fab Fragment Specific), Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5520 | 3 |
| DFL | Igm, Ferritin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | 3 |
| DFM | Ige, Ferritin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | |
| DFO | Igg, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | |
| DFQ | Sperm, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5800 | |
| DFS | Igm, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5550 | 33 |
| DFX | Sperm, Fitc, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5800 | |
| DFZ | Igg (Gamma Chain Specific), Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 9 |
| DGA | Cohn Fraction Ii, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5220 | |
| DGB | Seminal Fluid, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5800 | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 114 |
| DGD | Igg, Ferritin, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 3 |
| DGE | Igd, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 2 |
| DGG | Igd, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | |
| DGH | Igd, Peroxidase, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 1 |
| DGI | Breast Milk, Rhodamine, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5170 | |
| DGJ | Colostrum, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5230 | 1 |
| DGK | Igg, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 2 |
| DGL | Ige, Rhodamine, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | |
| DGM | Breast Milk, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5170 | |
| DGN | Breast Milk, Fitc, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5170 | |
| DGO | Ige, Peroxidase, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 15 |
| DGP | Ige, Fitc, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5510 | 4 |
| DGQ | Whole Blood Plasma, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5700 | 1 |
| DGR | Whole Human Serum, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5700 | 5 |
| DGW | System, Test, Hypersensitivity Pneumonitis | 第 2 类 | 21 CFR 866.5500 | |
| DGX | Ng1m(A), Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5065 | 1 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 第 2 类 | 21 CFR 866.5750 | 268 |
| DHC | System, Test, Systemic Lupus Erythematosus | 第 2 类 | 21 CFR 866.5820 | 16 |
| DHF | D/Km-1, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5065 | 1 |
| DHI | Ng3m(Bo), Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5065 | 1 |
| DHL | Protein, Complement, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.4100 | 4 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 第 2 类 | 21 CFR 866.5100 | 110 |
| DHQ | Ng3m(G), Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5065 | |
| DHR | System, Test, Rheumatoid Factor | 第 2 类 | 21 CFR 866.5775 | 144 |
| DHX | System, Test, Carcinoembryonic Antigen | 第 2 类 | 21 CFR 866.6010 | 28 |
| DHY | Ng4m(A), Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5065 | 1 |
| JFQ | P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin | 第 2 类 | 21 CFR 866.5210 | |
| JFR | Indirect Copper Assay, Ceruloplasmin | 第 2 类 | 21 CFR 866.5210 | 2 |
| JHR | Radioimmunoassay, Immunoglobulins (D, E) | 第 2 类 | 21 CFR 866.5510 | 9 |
| JKM | Immunochemical, Bence-Jones Protein | 第 2 类 | 21 CFR 866.5150 | 4 |
| JMG | Radioimmunoassay (Two-Site Solid Phase), Ferritin | 第 2 类 | 21 CFR 866.5340 | 24 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 第 2 类 | 21 CFR 866.5870 | 22 |
| JNM | Immunochemical, Transferrin | 第 2 类 | 21 CFR 866.5880 | 3 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 第 2 类 | 21 CFR 866.5630 | 53 |
| JZH | Factor B, Antigen, Antiserum, Control | 第 2 类 | 21 CFR 866.5320 | 6 |
| JZJ | Prealbumin, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5060 | 11 |
| JZO | System, Test, Thyroid Autoantibody | 第 2 类 | 21 CFR 866.5870 | 92 |
| JZP | Plates, Ouchterlony Agar | 第 1 类 | 21 CFR 866.4600 | 1 |
| JZQ | Plates And Equipment, Radial Immunodiffusion | 第 1 类 | 21 CFR 866.4800 | 7 |
| JZR | Support Gels | 第 1 类 | 21 CFR 866.4900 | 2 |
| JZS | Electrophoresis Instrumentation | 第 1 类 | 21 CFR 866.4500 | 6 |
| JZT | Fluorometer | 第 1 类 | 21 CFR 866.4520 | 14 |
| JZW | Nephelometer | 第 1 类 | 21 CFR 866.4540 | 11 |
| JZX | Equipment, Rocket Immunoelectrophoresis | 第 1 类 | 21 CFR 866.4830 | 1 |
| KHT | Fraction V, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5370 | 1 |
| KTK | Reagent, Immunoassay, Carbonic Anhydrase B And C | 第 1 类 | 21 CFR 866.5200 | |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 第 2 类 | 21 CFR 866.5100 | 19 |
| KTM | C3-Indirect Immunofluorescent Solid Phase | 第 2 类 | 21 CFR 866.5240 | |
| KTN | System, Test, Infectious Mononucleosis | 第 2 类 | 21 CFR 866.5640 | 59 |
| KTO | Reagent, Immunoassay, Igg | 第 1 类 | 21 CFR 866.5530 | 2 |
| KTP | Complement C3b Activator Immunoassay Reagents | 第 2 类 | 21 CFR 866.5260 | 1 |
| KTQ | Reagent, Complement | 第 1 类 | 21 CFR 866.4100 | 6 |
| KTS | Second Antibody (Species Specific Anti-Animal Gamma Globulin) | 第 2 类 | 21 CFR 866.5510 | 4 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 第 2 类 | 21 CFR 866.5100 | 112 |
| LKJ | Antinuclear Antibody, Antigen, Control | 第 2 类 | 21 CFR 866.5100 | 50 |
| LKL | Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5420 | 11 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 第 2 类 | 21 CFR 866.5100 | 23 |
| LKP | Anti-Sm Antibody, Antigen And Control | 第 2 类 | 21 CFR 866.5100 | 28 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 第 2 类 | 21 CFR 866.5100 | 182 |
| LOJ | Kit, Test,Alpha-Fetoprotein For Testicular Cancer | 第 2 类 | 21 CFR 866.6010 | 17 |
| LOQ | Device, General Purpose, Hematology | 第 2 类 | 21 CFR 866.6010 | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 第 2 类 | 21 CFR 866.5100 | 29 |
| LSW | Anti-Dna Antibody, Antigen And Control | 第 2 类 | 21 CFR 866.5100 | 8 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 第 2 类 | 21 CFR 866.6010 | 34 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 第 2 类 | 21 CFR 866.6010 | 26 |
| LYE | Cytokeratins | 第 2 类 | 21 CFR 866.5550 | 2 |
| MGA | Alpha-1 Microglobulin, Antigen, Antiserum, Control | 第 1 类 | 21 CFR 866.5400 | 2 |
| MID | System, Test, Anticardiolipin Immunological | 第 2 类 | 21 CFR 866.5660 | 94 |
| MLE | Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control | 第 2 类 | 21 CFR 866.5110 | 3 |
| MLH | Strip, Hama Igg, Elisa, In Vitro Test System | 第 2 类 | 21 CFR 866.5510 | |
| MMW | System, Test, Tumor Marker, Monitoring, Bladder | 第 2 类 | 21 CFR 866.6010 | 9 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 第 2 类 | 21 CFR 866.5660 | 75 |
| MOI | System, Test, Immunological, Antigen, Tumor | 第 2 类 | 21 CFR 866.6010 | 28 |
| MQA | Anti-Ribosomal P Antibodies | 第 2 类 | 21 CFR 866.5100 | 4 |
| MST | Antibodies, Gliadin | 第 2 类 | 21 CFR 866.5750 | 42 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 第 2 类 | 21 CFR 866.5660 | 46 |
| MSW | System, Test, Thyroglobulin | 第 2 类 | 21 CFR 866.6010 | 13 |
| MUT | Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Manage | 第 2 类 | 21 CFR 866.6010 | |