| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 第 1 类 | 21 CFR 866.2660 | 16 |
| JSY | Kit, Identification, Mycobacteria | 第 1 类 | 21 CFR 866.2660 | 5 |
| JSZ | Kit, Identification, Pseudomonas | 第 1 类 | 21 CFR 866.2660 | 1 |
| JTA | Monitor, Microbial Growth | 第 1 类 | 21 CFR 866.2560 | 11 |
| JTB | Device, Media Dispensing/Stacking | 第 1 类 | 21 CFR 866.2440 | 2 |
| JTC | Device, Microtiter Diluting/Dispensing | 第 1 类 | 21 CFR 866.2500 | 66 |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 第 1 类 | 21 CFR 866.2160 | 12 |
| JTM | Anaerobic Box Glove | 第 1 类 | 21 CFR 866.2120 | 1 |
| JTN | Susceptibility Test Discs, Antimicrobial | 第 2 类 | 21 CFR 866.1620 | 331 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 第 1 类 | 21 CFR 866.2660 | 244 |
| JTQ | Bath, Incubators/Water, All | 第 1 类 | 21 CFR 866.2540 | 12 |
| JTR | Kit, Quality Control For Culture Media | 第 1 类 | 21 CFR 866.2480 | 12 |
| JTT | Susceptibility Test Powders, Antimicrobial | 第 2 类 | 21 CFR 866.1640 | 14 |
| JTW | System, Transport, Aerobic | 第 1 类 | 21 CFR 866.2900 | 43 |
| JTX | Transport Systems, Anaerobic | 第 1 类 | 21 CFR 866.2900 | 8 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 第 2 类 | 21 CFR 866.2410 | 83 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/ | 第 2 类 | 21 CFR 866.1700 | 74 |
| JWK | Antigen, Positive Control, Cryptococcus Neoformans | 第 2 类 | 21 CFR 866.3165 | 1 |
| JWL | Antigen, Treponema Pallidum For Fta-Abs Test | 第 2 类 | 21 CFR 866.3830 | 4 |
| JWT | Antigen, Cf, Aspergillus Spp. | 第 1 类 | 21 CFR 866.3040 | 5 |
| JWW | Antigen, Cf, B. Dermatitidis | 第 2 类 | 21 CFR 866.3060 | 3 |
| JWX | Kit, Screening, Staphylococcus Aureus | 第 1 类 | 21 CFR 866.2660 | 20 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 第 2 类 | 21 CFR 866.1640 | 441 |
| JWZ | Kit, Screening, Trichomonas | 第 1 类 | 21 CFR 866.2660 | 11 |
| JXA | Kit, Screening, Urine | 第 1 类 | 21 CFR 866.2660 | 44 |
| JXB | Kit, Identification, Yeast | 第 1 类 | 21 CFR 866.2660 | 16 |
| JXC | Kit, Screening, Yeast | 第 1 类 | 21 CFR 866.2660 | 6 |
| KFG | Antiserum, Positive Control, Aspergillus Spp. | 第 1 类 | 21 CFR 866.3040 | 5 |
| KFH | Antiserum, Positive Control, Blastomyces Dermatitidis | 第 2 类 | 21 CFR 866.3060 | 4 |
| KFI | Strip, Virulence, Corynebacterium Diphtheriae | 第 1 类 | 21 CFR 866.3140 | |
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | 第 2 类 | 21 CFR 866.3220 | 18 |
| KLH | Antisera, C. Acnes | 第 1 类 | 21 CFR 866.3140 | 1 |
| KZB | Automated Colony Counter | 第 1 类 | 21 CFR 866.2170 | 1 |
| KZC | Manual Colony Counter | 第 1 类 | 21 CFR 866.2180 | |
| KZI | Culture Media, Enriched | 第 1 类 | 21 CFR 866.2330 | 51 |
| KZJ | Device, Gas Generating | 第 1 类 | 21 CFR 866.2580 | 18 |
| KZK | Reader, Zone, Automated | 第 1 类 | 21 CFR 866.2850 | 3 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 第 2 类 | 21 CFR 866.3510 | 94 |
| LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 第 2 类 | 21 CFR 866.3900 | 17 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 第 2 类 | 21 CFR 866.3175 | 58 |
| LGA | Device, Oxidase Test For Gonorrhea | 第 3 类 | 21 CFR 866.2420 | |
| LGB | Gonococcal Antibody Tests | 第 3 类 | 21 CFR 866.3290 | |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specifi | 第 2 类 | 21 CFR 866.3305 | 38 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 第 2 类 | 21 CFR 866.3780 | 106 |
| LHJ | Staphylococcus Aureus Protein A Insoluble | 第 1 类 | 21 CFR 866.3700 | 3 |
| LHK | Antigen, Id, Candida Albicans | 第 2 类 | 21 CFR 866.3165 | 4 |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 第 2 类 | 21 CFR 866.3300 | 18 |
| LHT | Staphylococcus Aureus Somatic Antigens | 第 1 类 | 21 CFR 866.3700 | 13 |
| LHW | Erythrocyte Suspension, Multi Species, Serological Reagent And Equipme | 第 1 类 | 21 CFR 866.3720 | 4 |
| LIA | Antigens, All Groups, Shigella Spp. | 第 2 类 | 21 CFR 866.3660 | 1 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 第 1 类 | 21 CFR 866.2660 | 43 |
| LIC | Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae | 第 2 类 | 21 CFR 866.3390 | 9 |
| LIE | Reagent/Device, Inoculum Calibration | 第 2 类 | 21 CFR 866.1640 | 7 |
| LIN | Antisera, Conjugated Fluorescent, Cytomegalovirus | 第 2 类 | 21 CFR 866.3175 | 17 |
| LIO | Device, Specimen Collection | 第 1 类 | 21 CFR 866.2900 | 63 |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 第 2 类 | 21 CFR 866.3830 | 35 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 第 1 类 | 21 CFR 866.3405 | 33 |
| LIR | Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae | 第 2 类 | 21 CFR 866.3390 | 3 |
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 第 1 类 | 21 CFR 866.3520 | 11 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 第 1 类 | 21 CFR 866.3120 | 67 |
| LJF | Device, Antimicrobial Drug Removal | 第 1 类 | 21 CFR 866.2560 | 4 |
| LJG | Quality Control Slides | 第 1 类 | 21 CFR 866.2660 | 27 |
| LJK | Antisera, If, Toxoplasma Gondii | 第 2 类 | 21 CFR 866.3780 | 6 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 第 1 类 | 21 CFR 866.3235 | 23 |
| LJO | Antigen, Iha, Cytomegalovirus | 第 2 类 | 21 CFR 866.3175 | 12 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 第 1 类 | 21 CFR 866.3120 | 35 |
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 第 1 类 | 21 CFR 866.3380 | 8 |
| LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | 第 1 类 | 21 CFR 866.3375 | 13 |
| LKA | Culture Media, Antimicrobial Susceptibility Test | 第 2 类 | 21 CFR 866.1700 | 5 |
| LKC | Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus | 第 2 类 | 21 CFR 866.3305 | |
| LKH | Antisera, Immunoperoxidase, Chlamydia Spp. | 第 1 类 | 21 CFR 866.3120 | 8 |
| LKI | Antisera, Fluorescent, Chlamydia Spp. | 第 1 类 | 21 CFR 866.3120 | 6 |
| LKQ | Antibody Igm,If, Cytomegalovirus Virus | 第 2 类 | 21 CFR 866.3175 | 18 |
| LKS | Device, Parasite Concentration | 第 1 类 | 21 CFR 866.2900 | 13 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 第 1 类 | 21 CFR 866.3480 | 23 |
| LLA | Direct Agglutination Test, Toxoplasma Gondii | 第 2 类 | 21 CFR 866.3780 | 4 |
| LLH | Reagents, Clostridium Difficile Toxin | 第 1 类 | 21 CFR 866.2660 | 42 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 第 1 类 | 21 CFR 866.3235 | 27 |
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | 第 2 类 | 21 CFR 866.3310 | 26 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 第 2 类 | 21 CFR 866.3172 | 1 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubatio | 第 2 类 | 21 CFR 866.1645 | 289 |
| LOO | Reagent, Leishmanii Serological | 第 1 类 | 21 CFR 866.3870 | 2 |
| LOP | Solution, Antimicrobial | 第 2 类 | 21 CFR 866.1640 | 3 |
| LQF | Dna-Reagents, Mycobacterium Spp. | 第 1 类 | 21 CFR 866.3370 | 15 |
| LQG | Dna-Reagents, Mycoplasma Spp. | 第 1 类 | 21 CFR 866.3375 | 1 |
| LQH | Dna-Reagents, Legionella | 第 2 类 | 21 CFR 866.3300 | 2 |
| LQL | Gram Positive Identification Panel | 第 1 类 | 21 CFR 866.2660 | 11 |
| LQM | Gram Negative Identification Panel | 第 1 类 | 21 CFR 866.2660 | 7 |
| LQN | Latex Agglutination Assay, Rubella | 第 2 类 | 21 CFR 866.3510 | 13 |
| LQO | Dna-Reagents, Campylobacter Spp. | 第 1 类 | 21 CFR 866.3110 | 4 |
| LQP | Campylobacter Spp. | 第 1 类 | 21 CFR 866.3110 | 12 |
| LRF | Candida Spp., Direct Antigen, Id | 第 2 类 | 21 CFR 866.3165 | 3 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Syst | 第 2 类 | 21 CFR 866.1640 | 45 |
| LRH | Instrument For Auto Reader Of Overnight Microorganism Identification S | 第 1 类 | 21 CFR 866.2660 | 4 |
| LSC | Neisseria Controls | 第 1 类 | 21 CFR 866.2660 | 7 |
| LSD | Rubella, Other Assays | 第 2 类 | 21 CFR 866.3510 | |
| LSE | Epstein-Barr Virus, Other | 第 1 类 | 21 CFR 866.3235 | 56 |
| LSF | Dna-Reagents, Epstein-Barr Virus | 第 1 类 | 21 CFR 866.3235 | |
| LSG | Candida Species, Antibody Detection | 第 2 类 | 21 CFR 866.3165 | |
| LSH | Antigen, Blastomyces Dermatitidis, Other | 第 2 类 | 21 CFR 866.3060 | |
| LSI | Antiserum, Blastomyces Dermatitidis, Other | 第 2 类 | 21 CFR 866.3060 | |
| LSJ | Antigen, Rubella, Other | 第 2 类 | 21 CFR 866.3510 | |
| LSK | Dna-Reagents, Chlamydia | 第 1 类 | 21 CFR 866.3120 | 8 |
| LSL | Dna-Reagents, Neisseria | 第 2 类 | 21 CFR 866.3390 | 45 |
| LSM | Dna-Reagents, Salmonella Spp. | 第 2 类 | 21 CFR 866.3550 | |
| LSN | Dna-Reagents, Shigella Spp. | 第 2 类 | 21 CFR 866.3660 | |
| LSO | Dna-Reagents, Cytomegalovirus | 第 2 类 | 21 CFR 866.3175 | |
| LSQ | Reagent, Rickettsia Serological | 第 1 类 | 21 CFR 866.3500 | 4 |
| LSR | Reagent, Borrelia Serological Reagent | 第 2 类 | 21 CFR 866.3830 | 112 |
| LTS | Test Reagents, Neisseria Gonorrhoeae Biochemical | 第 1 类 | 21 CFR 866.2660 | 1 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 第 2 类 | 21 CFR 866.1640 | 50 |
| LTW | Susceptibility Test Cards, Antimicrobial | 第 2 类 | 21 CFR 866.1640 | 16 |
| LTX | Discs, Elution | 第 2 类 | 21 CFR 866.1620 | 2 |
| LYF | Pneumocystis Carinii | 第 2 类 | 21 CFR 866.3780 | 7 |
| LYR | Helicobacter Pylori | 第 1 类 | 21 CFR 866.3110 | 91 |
| MBT | Dna-Probe, Reagent, Histoplasma Capsulatum | 第 2 类 | 21 CFR 866.3320 | 1 |
| MCB | Antigen, C. Difficile | 第 1 类 | 21 CFR 866.2660 | 10 |
| MCC | Dna-Probe, Haemophilus Spp. | 第 2 类 | 21 CFR 866.3300 | 2 |
| MCD | Antigen, Ebv, Capsid | 第 1 类 | 21 CFR 866.3235 | 8 |
| MCE | Respiratory Syncytial Virus - Elisa | 第 1 类 | 21 CFR 866.3480 | 2 |
| MCG | Dna-Probe, Agent, Listeria | 第 1 类 | 21 CFR 866.3355 | |
| MCS | Dna-Probe, Staphylococcus Aureus | 第 1 类 | 21 CFR 866.3700 | 1 |
| MCT | Dna-Probe, Strep Pneumoniae | 第 1 类 | 21 CFR 866.3740 | 1 |
| MDB | System, Blood Culturing | 第 1 类 | 21 CFR 866.2560 | 68 |
| MDC | Dna-Probe - Blastomyces Dermatitidis | 第 2 类 | 21 CFR 866.3060 | 1 |
| MDE | Dna-Probe, Reagents, Cryptococcal | 第 2 类 | 21 CFR 866.3165 | 1 |
| MDF | Dna-Probe, Reagents, Coccidioides Immitis | 第 2 类 | 21 CFR 866.3135 | 1 |
| MDJ | Reagents, Cysticercosis | 第 1 类 | 21 CFR 866.3200 | 1 |
| MDK | Dna-Probe, Reagents, Streptococcal | 第 1 类 | 21 CFR 866.3740 | 4 |
| MDT | Elisa, Trichinella Spiralis | 第 1 类 | 21 CFR 866.3850 | |
| MDU | Antigen, Elisa, Cryptococcus | 第 2 类 | 21 CFR 866.3165 | 2 |
| MGM | C. Trachomatis (Chlamydia Group) | 第 1 类 | 21 CFR 866.3120 | |
| MHI | Giardia Spp. | 第 2 类 | 21 CFR 866.3220 | 27 |
| MHJ | Cryptosporidium Spp. | 第 2 类 | 21 CFR 866.3220 | 15 |
| MIU | Enzyme Linked Immunosorbent Assay, T. Cruzi | 第 1 类 | 21 CFR 866.3870 | 6 |
| MIV | Immunofluorescent Assay, T. Cruzi | 第 1 类 | 21 CFR 866.3870 | |
| MIY | Enzyme Linked Immunosorbent Assay, Coccidioides Immitis | 第 2 类 | 21 CFR 866.3135 | 1 |
| MIZ | Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum | 第 2 类 | 21 CFR 866.3320 | 2 |
| MJA | Susceptibility Test Powders, Antimycobacterial | 第 2 类 | 21 CFR 866.1640 | 5 |
| MJD | Culture Media, Antimycobacteria, Susceptibility Test | 第 2 类 | 21 CFR 866.1700 | 3 |
| MJE | Culture Media, Antifungal, Susceptibility Test | 第 2 类 | 21 CFR 866.1700 | 1 |
| MJH | Legionella, Spp., Elisa | 第 2 类 | 21 CFR 866.3300 | 10 |
| MJK | Dna Probe, Trichomonas Vaginalis | 第 1 类 | 21 CFR 866.2660 | 1 |
| MJL | Eia, Blastomyces Dermatitidis | 第 2 类 | 21 CFR 866.3060 | 2 |
| MJM | Dna Probe, Gardnerella Vaginalis | 第 1 类 | 21 CFR 866.2660 | 2 |
| MKT | Hepatitis Viral B Dna Detection | 第 2 类 | 21 CFR 866.3174 | |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | 第 1 类 | 21 CFR 866.3120 | 19 |
| MLA | Dna Probe, Yeast | 第 1 类 | 21 CFR 866.2660 | 2 |
| MSQ | Test, Urea (Breath Or Blood) | 第 1 类 | 21 CFR 866.3110 | 17 |
| MWA | System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex | 第 2 类 | 21 CFR 866.3372 | |
| MXB | Test, Vaginal, Bacterial Sialidase | 第 1 类 | 21 CFR 866.2660 | 2 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 第 2 类 | 21 CFR 866.3305 | 20 |
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 第 2 类 | 21 CFR 866.3305 | 10 |
| MYI | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus C | 第 2 类 | 21 CFR 866.1640 | 10 |
| MYR | Test, Donor, Syphilis, Antigens, Treponemal | 第 2 类 | 21 CFR 866.3830 | |
| MZC | System, Detection, Bacterial, For Platelet Transfusion Products | 第 1 类 | 21 CFR 866.2560 | |
| MZF | Test, Hiv Detection | 第 2 类 | 21 CFR 866.3956 | |
| MZO | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | 第 2 类 | 21 CFR 866.3169 | 2 |
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection O | 第 2 类 | 21 CFR 866.3170 | 4 |
| NDZ | Assay, Nucleic Acid Amplification, Growth Identification, Mycobacteriu | 第 1 类 | 21 CFR 866.3370 | 1 |
| NGS | Assay, Endotoxin Activity, Chemiluminescent | 第 2 类 | 21 CFR 866.3210 | 2 |
| NGZ | Susceptibility Test Plate, Antifungal | 第 2 类 | 21 CFR 866.1640 | 21 |
| NHT | Assay, Nucleic Acid Amplification, Bacillus Anthracis | 第 2 类 | 21 CFR 866.3045 | 6 |
| NHY | Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus | 第 1 类 | 21 CFR 866.3480 | |
| NHZ | Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus | 第 1 类 | 21 CFR 866.3400 | |
| NIA | Assay, Direct, Nucleic Acid Amplification, Influenza Virus | 第 1 类 | 21 CFR 866.3330 | |
| NIJ | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Spe | 第 2 类 | 21 CFR 866.1640 | 6 |
| NJO | System, Mycolic Acid Analysis, Mycobacterium Tuberculosis | 第 1 类 | 21 CFR 866.3370 | 1 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct | 第 1 类 | 21 CFR 866.3740 | 18 |
| NOM | Antigen, Galactomannan, Aspergillus Spp. | 第 1 类 | 21 CFR 866.3040 | 4 |
| NOP | Elisa, Antibody, West Nile Virus | 第 2 类 | 21 CFR 866.3940 | 10 |
| NPO | Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody | 第 2 类 | 21 CFR 866.3045 | 1 |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant St | 第 2 类 | 21 CFR 866.1640 | 24 |
| NQZ | Antigen, Invasive Fungal Pathogens | 第 2 类 | 21 CFR 866.3050 | 2 |
| NRL | Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis | 第 2 类 | 21 CFR 866.3045 | 1 |
| NTM | Antigen, Inflammatory Response Marker, Sepsis | 第 2 类 | 21 CFR 866.3210 | 3 |
| NVQ | Bacteriophage And Controls, B. Anthracis Lysis | 第 2 类 | 21 CFR 866.3045 | 2 |
| NWZ | Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids | 第 2 类 | 21 CFR 866.3045 | 1 |
| NXD | Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Linea | 第 2 类 | 21 CFR 866.3332 | 3 |
| NXX | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rn | 第 1 类 | 21 CFR 866.3700 | 4 |
| NZB | Quality Control Material, Genetics, Dna | 第 2 类 | 21 CFR 866.5910 | 4 |
| NZS | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rn | 第 1 类 | 21 CFR 866.2660 | 3 |
| OAH | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, En | 第 1 类 | 21 CFR 866.3740 | 4 |
| OAI | Assay, Enterovirus Nucleic Acid | 第 2 类 | 21 CFR 866.3225 | 2 |
| OAX | Plasmodium Spp. Detection Reagents | 第 2 类 | 21 CFR 866.3402 | 1 |
| OBF | Assay, Genotyping, Hepatitis C Virus | 第 2 类 | 21 CFR 866.3170 | |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 第 2 类 | 21 CFR 866.3980 | 79 |
| OEH | Joint Biological Agent Identification And Diagnostic System (Jbaids) T | 第 2 类 | 21 CFR 866.3280 | 2 |
| OEM | Human Metapneumovirus (Hmpv) Rna Assay System | 第 2 类 | 21 CFR 866.3980 | 6 |
| OEP | Influenza A Virus Subtype Differentiation Nucleic Acid Assay | 第 2 类 | 21 CFR 866.3980 | 1 |
| OID | Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Exclude | 第 1 类 | 21 CFR 866.2900 | |
| OJY | Device To Detect Or Measure Nucleic Acid From Viruses Associated With | 第 2 类 | 21 CFR 866.3236 | 1 |
| OMG | Antisera, Fluorescent, Human Metapneumovirus | 第 2 类 | 21 CFR 866.3980 | 4 |
| OMI | Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv | 第 2 类 | 21 CFR 866.3510 | 2 |
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | 第 1 类 | 21 CFR 866.2660 | 5 |
| OMS | Novel Influenza A Virus, A/H5 Ns1 Protein | 第 2 类 | 21 CFR 866.3332 | 1 |
| OOU | Parainfluenza Multiplex Nucleic Acid Assay | 第 2 类 | 21 CFR 866.3980 | 5 |
| OPL | Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Vari | 第 2 类 | 21 CFR 866.3510 | 3 |
| OPM | Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herp | 第 2 类 | 21 CFR 866.3510 | 1 |
| OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 第 2 类 | 21 CFR 866.3305 | 12 |