Microbiology device product codes

554 FDA product codes. All panels.

• GLZ — Antigens, If, Toxoplasma Gondii (Class II, 18 clearances)
• GMA — Antisera, Fluorescent, Sporothrix Schenekii (Class I, 1 clearances)
• GMB — Light, Wood'S, Fluorescence (Class I)
• GMD — Antisera, Latex Agglutination, Cryptococcus Neoformans (Class II, 10 clearances)
• GME — Antisera, Fluorescent, Cryptococcus Neoformans (Class II)
• GMG — Antigen, Latex Agglutination, Coccidioides Immitis (Class II, 5 clearances)
• GMH — Antiserum, Positive Control, Coccidioides Immitis (Class II, 5 clearances)
• GMI — Antigen, Cf And / Or Id, Coccidioides Immitis (Class II, 11 clearances)
• GMJ — Antigens, Histoplasma Capsulatum, All (Class II, 12 clearances)
• GMK — Antiserum, Positive Control, Histoplasma Capsulatum (Class II, 9 clearances)
• GML — Antisera, Fluorescent, Histoplasma Capsulatum (Class II)
• GMM — Antigens, Iha, Toxoplasma Gondii (Class II, 8 clearances)
• GMN — Antigens, Cf, Toxoplasma Gondii (Class II, 3 clearances)
• GMO — Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. (Class II)
• GMP — Antisera, Control For Nontreponemal Tests (Class II, 9 clearances)
• GMQ — Antigens, Nontreponemal, All (Class II, 32 clearances)
• GMR — Sera, Reactive And Non-Specific Control, Fta-Abs Test (Class II)
• GMS — Anti-Human Globulin, Fta-Abs Test (Class II, 3 clearances)
• GMT — Antigens, Ha, Treponema Pallidum (Class II, 9 clearances)
• GMW — Test, Sorbent, Fta-Abs (Class II)
• GMX — Antisera, Fluorescent Antibody For Fta-Abs Test (Class II)
• GMY — Antisera, Fluorescent, All Types, Escherichia Coli (Class I, 2 clearances)
• GMZ — Antigens, All Types, Escherichia Coli (Class I, 14 clearances)
• GNA — Antisera, All Types, Escherichia Coli (Class I, 12 clearances)
• GNB — Antisera, All Types, Shigella Spp. (Class II, 41 clearances)
• GNC — Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. (Class II, 60 clearances)
• GND — Antigen, Iha, T. Cruzi (Class I)
• GNE — Antigen, Latex Agglutination, T. Cruzi (Class I, 1 clearances)
• GNF — Antigen, Cf, T. Cruzi (Class I)
• GNG — Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6 (Class I, 2 clearances)
• GNH — Antigen, Fluorescent Antibody Test, Schistosoma Mansoni (Class I, 2 clearances)
• GNI — Antisera, Neutralization, Echovirus 1-34 (Class I)
• GNJ — Antigens, Ha, Echovirus 1-34 (Class I, 1 clearances)
• GNK — Antisera, Cf, Echovirus 1-34 (Class I, 3 clearances)
• GNL — Antigens, Cf (Including Cf Control), Echovirus 1-34 (Class I, 2 clearances)
• GNM — Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 (Class I, 9 clearances)
• GNN — Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6 (Class I, 1 clearances)
• GNO — Antisera, Cf, Coxsackievirus A 1-24, B 1-6 (Class I, 1 clearances)
• GNP — Antiserum, Cf, Epstein-Barr Virus (Class I, 20 clearances)
• GNQ — Antigen, Cf (Including Cf Control), Epstein-Barr Virus (Class I)
• GNR — Antisera, Neutralization, Influenza Virus A, B, C (Class I, 1 clearances)
• GNS — Antisera, Hai, Influenza Virus A, B, C (Class I, 9 clearances)
• GNT — Antigens, Ha (Including Ha Control), Influenza Virus A, B, C (Class I, 5 clearances)
• GNW — Antisera, Cf, Influenza Virus A, B, C (Class I, 16 clearances)
• GNX — Antigens, Cf (Including Cf Control), Influenza Virus A, B, C (Class I, 18 clearances)
• GNY — Antisera, Fluorescent, Adenovirus 1-33 (Class I, 4 clearances)
• GNZ — Antisera, Neutralization, Adenovirus 1-33 (Class I)
• GOA — Antisera, Cf, Adenovirus 1-33 (Class I, 1 clearances)
• GOB — Antigens, Ha (Including Ha Control), Adenovirus 1-33 (Class I, 1 clearances)
• GOC — Antisera, Hai, Adenovirus 1-33 (Class I)
• GOD — Antigens, Cf (Including Cf Control), Adenovirus 1-33 (Class I, 11 clearances)
• GOE — Antisera, Fluorescent, Poliovirus 1-3 (Class I, 7 clearances)
• GOF — Antisera, Neutralization, Poliovirus 1-3 (Class I)
• GOG — Antisera, Cf, Poliovirus 1-3 (Class I, 3 clearances)
• GOH — Antigens, Cf (Including Cf Control), Poliovirus 1-3 (Class I)
• GOI — Antiserum, Fluorescent, Rabies Virus (Class II, 2 clearances)
• GOJ — Antisera, Neutralization, Rubella (Class II)
• GOK — Antisera, Hai (Including Hai Control), Rubella (Class II, 11 clearances)
• GOL — Antigen, Ha (Including Ha Control), Rubella (Class II, 21 clearances)
• GOM — Antisera, Cf, Rubella (Class II, 2 clearances)
• GON — Antigen, Cf (Including Cf Control), Rubella (Class II, 5 clearances)
• GOO — Antisera, Fluorescent, All Globulins, Salmonella Spp. (Class II)
• GOP — Antisera, C. Acnes (553, 605) (Class I)
• GOS — Antiserum, Fluorescent, C. Diphtheriae (Class I)
• GOT — Antigen, B. Parapertussis (Class I)
• GOW — Antisera, Agglutinating, B. Parapertussis (Class I)
• GOX — Antigen, B. Pertussis (Class I, 1 clearances)
• GOY — Antisera, Agglutinating, B. Pertussis, All (Class I, 1 clearances)
• GOZ — Antisera, Fluorescent, B. Pertussis (Class I)
• GPD — Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus (Class I)
• GPE — Antisera, Positive Control, Echinococcus Spp. (Class I)
• GPF — Antigen, Agglutinating, Echinococcus Spp. (Class I, 1 clearances)
• GPG — Antigen, Latex Agglutination, Trichinella Spiralis (Class I, 2 clearances)
• GPH — Antiserum, Bentonite Flocculation, Trichinella Spiralis (Class I)
• GPI — Antigen, Bentonite Flocculation, Trichinella Spiralis (Class I)
• GPJ — Antiserum, Fluorescent, Q Fever (Class I, 2 clearances)
• GPK — Antiserum, Rickettsial Pox (Class I)
• GPM — Antiserum, Murine Typhus Fever (Class I, 1 clearances)
• GPN — Antiserum, Typhus Fever (Class I, 1 clearances)
• GPO — Antigen, Cf, Typhus Fever Group (Class I, 1 clearances)
• GPP — Antiserum, Rocky Mountain Spotted Fever (Class I, 1 clearances)
• GPQ — Antigen, Cf, Spotted Fever Group (Class I)
• GPR — Antiserum, Cf, Q Fever (Class I)
• GPS — Antigen, Cf, Q Fever (Class I, 1 clearances)
• GPT — Antiserum, Cf, Psittacosis (Chlamydia Group) (Class I, 1 clearances)
• GPW — Antigen, Cf, Psittacosis (Chlamydia Group) (Class I, 4 clearances)
• GPX — Antisera, Neutralizion, Reovirus 1-3 (Class I)
• GPY — Antisera, Hai, Reovirus 1-3 (Class I)
• GPZ — Antisera, Cf, Reovirus 1-3 (Class I)
• GQA — Antigens, Ha (Including Ha Control), Reovirus 1-3 (Class I)
• GQB — Antigens, Cf (Including Cf Control), Reovirus 1-3 (Class I)
• GQC — Antisera, Cf, Equine Encephalitis Virus, Eee, Wee (Class I, 2 clearances)
• GQD — Antigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee (Class I)
• GQE — Antisera, Neutralization, All Types, Rhinovirus (Class I)
• GQF — Antiserum, Neutralization, Respiratory Syncytial Virus (Class I)
• GQG — Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus (Class I, 32 clearances)
• GQH — Antigen, Cf (Including Cf Control), Cytomegalovirus (Class II, 19 clearances)
• GQI — Antiserum, Cf, Cytomegalovirus (Class II, 18 clearances)
• GQJ — Antiserum, Cf, Lymphocytic Choriomeningitis Virus (Class I)
• GQK — Antigen, Cf, Lymphocytic Choriomeningitis Virus (Class I)
• GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II, 37 clearances)
• GQM — Antisera, Neutralization, Herpesvirus Hominis (Class II, 3 clearances)
• GQN — Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 (Class II, 34 clearances)
• GQO — Antisera, Cf, Herpesvirus Hominis 1,2 (Class II, 16 clearances)
• GQP — Antisera, Neutralization, Parainfluenza Virus 1-4 (Class I, 2 clearances)
• GQQ — Antisera, Hai, Parainfluenza Virus 1-4 (Class I, 1 clearances)
• GQR — Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4 (Class I, 1 clearances)
• GQS — Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 (Class I, 11 clearances)
• GQT — Antisera, Cf, Parainfluenza Virus 1-4 (Class I, 4 clearances)
• GQW — Antigen, Cf, (Including Cf Control), Varicella-Zoster (Class II, 10 clearances)
• GQX — Antiserum, Cf, Varicella-Zoster (Class II, 11 clearances)
• GQY — Antigen, Ha (Including Ha Control), Mumps Virus (Class I)
• GQZ — Antiserum, Neutralization, Mumps Virus (Class I)
• GRA — Antiserum, Fluorescent, Mumps Virus (Class I, 3 clearances)
• GRB — Antiserum, Cf, Mumps Virus (Class I, 2 clearances)
• GRC — Antigen, Cf (Including Cf Control), Mumps Virus (Class I, 3 clearances)
• GRD — Antiserum, Hai, Mumps Virus (Class I, 1 clearances)
• GRE — Antiserum, Fluorescent, Rubeola (Class I, 4 clearances)
• GRF — Antiserum, Cf, Rubeola (Class I, 2 clearances)
• GRG — Antiserum, Hai, Rubeola (Class I)
• GRH — Antigen, Ha (Including Ha Control), Rubeola (Class I)
• GRI — Antiserum, Neutralization, Rubeola (Class I)
• GRJ — Antigen, Cf, (Including Cf Control), Rubeola (Class I, 2 clearances)
• GRK — Antisera, Fluorescent, Echovirus 1-34 (Class I)
• GRL — Antigens, All Groups, Salmonella Spp. (Class II, 2 clearances)
• GRM — Antisera, All Groups, Salmonella Spp. (Class II, 69 clearances)
• GRO — Antisera, Fluorescent, All Types, Hemophilus Spp. (Class II, 4 clearances)
• GRP — Antisera, All Types, H. Influenza (Class II, 6 clearances)
• GRT — Antiserum, Fluorescent, Mycobacterium Tuberculosis (Class I, 1 clearances)
• GRW — Antisera, All Fluorescent, Leptospira Spp. (Class II)
• GRX — Antisera, All Leptospira Spp. (Class II)
• GRY — Antigens, All, Leptospira Spp. (Class II, 2 clearances)
• GRZ — Antisera, Fluorescent, All, Mycoplasma Spp. (Class I, 5 clearances)
• GSA — Antisera, All Mycoplasma Spp. (Class I, 6 clearances)
• GSB — Antigens, Cf, All, Mycoplasma Spp. (Class I, 5 clearances)
• GSD — Antiserum, Fluorescent, Erysipelothrix Rhusiopathiae (Class I)
• GSE — Antiserum, Erysipelothrix Rhusiopathiae (Class I)
• GSF — Antigen, Erysipelothrix Rhusiopathiae (Class I)
• GSG — Antisera, Fluorescent, All Types, Listeria Monocytogenes (Class I)
• GSH — Antisera, All Types, Listeria Monocytogenes (Class I, 1 clearances)
• GSI — Antigens, Slide And Tube, All Types, Listeria Monocytogenes (Class I, 1 clearances)
• GSJ — Antiserum, Fluorescent, Francisella Tularensis (Class II, 1 clearances)
• GSK — Antiserum, Francisella Tularensis (Class II, 1 clearances)
• GSL — Antigens, Slide And Tube, Francisella Tularensis (Class II, 1 clearances)
• GSM — Antisera, Fluorescent, Brucella Spp. (Class II, 4 clearances)
• GSN — Antiserum, Positive And Negative Febrile Antigen Control Serum (Class II, 3 clearances)
• GSO — Antigens (Febrile), Agglutination, Brucella Spp. (Class II, 12 clearances)
• GSP — Antiserum, Fluorescent, Campylobacter Fetus (Class I)
• GSQ — Antiserum, Vibrio Cholerae, All Varieties (Class II, 3 clearances)
• GSR — Antisera, Fluorescent, Pseudomonas Pseudomallei (Class II)
• GSS — Antisera, Fluorescent, Pseudomonas Aeruginosa (Class II, 1 clearances)
• GST — Antiserum, Pseudomonas Pseudomallei (Class II)
• GSW — Antiserum, Flavobacterium Meningosepticum, All Groups (Class I)
• GSX — Antisera, Acinetobacter Calcoaceticus, All Varieties (Class I)
• GSY — Antisera, Fluorescent, All Globulins, Proteus Spp. (Class I)
• GSZ — Antigens, Febrile (Weil-Felix), All Groups (Class I, 3 clearances)
• GTA — Antisera, All, Serratia Marcesans (Class I)
• GTB — Antisera, Fluorescent, All Types, Klebsiella Spp. (Class I)
• GTC — Antisera, All Types, Klebsiella Spp. (Class I, 1 clearances)
• GTD — Antisera, Fluorescent, All Globulins, Shigella Spp. (Class II)
• GTE — Antisera, Arizona Spp., All (Class I)
• GTF — Antisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp. (Class I)
• GTH — Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae (Class II, 3 clearances)
• GTI — Antisera, Fluorescent, All Groups, N. Meningitidis (Class II, 2 clearances)
• GTJ — Antisera, All Groups, N. Meningitidis (Class II, 16 clearances)
• GTL — Phages, Staphylococcal Typing, All Types (Class I)
• GTN — Antisera, Fluorescent, All Types, Staphylococcus Spp. (Class I, 4 clearances)
• GTO — Anti-Streptokinase (Class I)
• GTP — Exoenzymes, Multiple, Streptococcal (Class I, 3 clearances)
• GTQ — Antistreptolysin - Titer/Streptolysin O Reagent (Class I, 37 clearances)
• GTR — Antideoxyribonuclease, Streptococcus Spp. (Class I, 1 clearances)
• GTX — Antisera, Fluorescent, All Groups, Streptococcus Spp. (Class I, 2 clearances)
• GTY — Antigens, All Groups, Streptococcus Spp. (Class I, 44 clearances)
• GTZ — Antisera, All Groups, Streptococcus Spp. (Class I, 105 clearances)
• GWB — Antisera, Fluorescent, All Types, Streptococcus Pneumoniae (Class I, 2 clearances)
• GWC — Antisera, All Types, Streptococcus Pneumoniae (Class I, 9 clearances)
• GWD — Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp (Class II, 2 clearances)
• JRW — Antisera, Fluorescent, B. Parapertussis (Class I, 2 clearances)
• JRY — Antiserum, Fluorescent, Epstein-Barr Virus (Class I, 9 clearances)
• JRZ — Media, Culture, Amino Acid Assay (Class I)
• JSA — Culture Media, Antibiotic Assay (Class I, 8 clearances)
• JSB — Culture Media, Vitamin Assay (Class I)
• JSC — Culture Media, General Nutrient Broth (Class I, 52 clearances)
• JSD — Culture Media, Selective Broth (Class I, 26 clearances)
• JSE — Culture Media, Multiple Biochemical Test (Class I, 53 clearances)
• JSF — Culture Media, Single Biochemical Test (Class I, 87 clearances)
• JSG — Culture Media, Non-Selective And Non-Differential (Class I, 209 clearances)
• JSH — Culture Media, Non-Selective And Differential (Class I, 146 clearances)
• JSI — Culture Media, Selective And Differential (Class I, 285 clearances)
• JSJ — Culture Media, Selective And Non-Differential (Class I, 307 clearances)
• JSK — Supplement, Culture Media (Class I, 70 clearances)
• JSL — Culture Media, Anaerobic Transport (Class I, 8 clearances)
• JSM — Culture Media, Non-Propagating Transport (Class I, 111 clearances)
• JSN — Culture Media, Propagating Transport (Class I, 13 clearances)
• JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II, 40 clearances)
• JSP — Kit, Anaerobic Identification (Class I, 18 clearances)
• JSR — Kit, Identification, Dermatophyte (Class I, 1 clearances)
• JSS — Kit, Identification, Enterobacteriaceae (Class I, 49 clearances)
• JST — Kit, Fastidious Organisms (Class I, 6 clearances)
• JSW — Kit, Identification, Glucose Nonfermenter (Class I, 6 clearances)
• JSX — Kit, Identification, Neisseria Gonorrhoeae (Class I, 16 clearances)
• JSY — Kit, Identification, Mycobacteria (Class I, 5 clearances)
• JSZ — Kit, Identification, Pseudomonas (Class I, 1 clearances)
• JTA — Monitor, Microbial Growth (Class I, 11 clearances)
• JTB — Device, Media Dispensing/Stacking (Class I, 2 clearances)
• JTC — Device, Microtiter Diluting/Dispensing (Class I, 66 clearances)
• JTL — Plasma, Coagulase, Human, Horse And Rabbit (Class I, 12 clearances)
• JTM — Anaerobic Box Glove (Class I, 1 clearances)
• JTN — Susceptibility Test Discs, Antimicrobial (Class II, 327 clearances)
• JTO — Discs, Strips And Reagents, Microorganism Differentiation (Class I, 244 clearances)
• JTQ — Bath, Incubators/Water, All (Class I, 12 clearances)
• JTR — Kit, Quality Control For Culture Media (Class I, 12 clearances)
• JTS — Stains, Microbiologic (Class I, 40 clearances)
• JTT — Susceptibility Test Powders, Antimicrobial (Class II, 14 clearances)
• JTW — System, Transport, Aerobic (Class I, 43 clearances)
• JTX — Transport Systems, Anaerobic (Class I, 8 clearances)
• JTY — Culture Media, For Isolation Of Pathogenic Neisseria (Class II, 83 clearances)
• JTZ — Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth (Class II, 74 clearances)
• JWK — Antigen, Positive Control, Cryptococcus Neoformans (Class II, 1 clearances)
• JWL — Antigen, Treponema Pallidum For Fta-Abs Test (Class II, 4 clearances)
• JWT — Antigen, Cf, Aspergillus Spp. (Class I, 5 clearances)
• JWW — Antigen, Cf, B. Dermatitidis (Class II, 3 clearances)
• JWX — Kit, Screening, Staphylococcus Aureus (Class I, 20 clearances)
• JWY — Manual Antimicrobial Susceptibility Test Systems (Class II, 441 clearances)
• JWZ — Kit, Screening, Trichomonas (Class I, 11 clearances)
• JXA — Kit, Screening, Urine (Class I, 44 clearances)
• JXB — Kit, Identification, Yeast (Class I, 16 clearances)
• JXC — Kit, Screening, Yeast (Class I, 6 clearances)
• KFG — Antiserum, Positive Control, Aspergillus Spp. (Class I, 5 clearances)
• KFH — Antiserum, Positive Control, Blastomyces Dermatitidis (Class II, 4 clearances)
• KFI — Strip, Virulence, Corynebacterium Diphtheriae (Class I)
• KHW — Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (Class II, 18 clearances)
• KLH — Antisera, C. Acnes (Class I, 1 clearances)
• KTN — System, Test, Infectious Mononucleosis (Class II, 59 clearances)
• KZB — Automated Colony Counter (Class I, 1 clearances)
• KZC — Manual Colony Counter (Class I)
• KZI — Culture Media, Enriched (Class I, 51 clearances)
• KZJ — Device, Gas Generating (Class I, 18 clearances)
• KZK — Reader, Zone, Automated (Class I, 3 clearances)
• LFX — Enzyme Linked Immunoabsorbent Assay, Rubella (Class II, 94 clearances)
• LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster (Class II, 17 clearances)
• LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II, 58 clearances)
• LGA — Device, Oxidase Test For Gonorrhea (Class III)
• LGB — Gonococcal Antibody Tests (Class III)
• LGC — Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific (Class II, 38 clearances)
• LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II, 106 clearances)
• LHJ — Staphylococcus Aureus Protein A Insoluble (Class I, 3 clearances)
• LHK — Antigen, Id, Candida Albicans (Class II, 4 clearances)
• LHL — Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (Class II, 18 clearances)
• LHT — Staphylococcus Aureus Somatic Antigens (Class I, 13 clearances)
• LHW — Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment (Class I, 4 clearances)
• LIA — Antigens, All Groups, Shigella Spp. (Class II, 1 clearances)
• LIB — Device, General Purpose, Microbiology, Diagnostic (Class I, 43 clearances)
• LIC — Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae (Class II, 9 clearances)
• LIE — Reagent/Device, Inoculum Calibration (Class II, 7 clearances)
• LIN — Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II, 17 clearances)
• LIO — Device, Specimen Collection (Class I, 63 clearances)
• LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II, 35 clearances)
• LIQ — Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I, 33 clearances)
• LIR — Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae (Class II, 3 clearances)
• LJB — Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (Class I, 11 clearances)
• LJC — Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) (Class I, 67 clearances)
• LJF — Device, Antimicrobial Drug Removal (Class I, 4 clearances)
• LJG — Quality Control Slides (Class I, 27 clearances)
• LJK — Antisera, If, Toxoplasma Gondii (Class II, 6 clearances)
• LJN — Antibody Igm, If, Epstein-Barr Virus (Class I, 23 clearances)
• LJO — Antigen, Iha, Cytomegalovirus (Class II, 12 clearances)
• LJP — Antiserum, Fluorescent, Chlamydia Trachomatis (Class I, 35 clearances)
• LJY — Enzyme Linked Immunoabsorbent Assay, Mumps Virus (Class I, 8 clearances)
• LJZ — Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (Class I, 13 clearances)
• LKA — Culture Media, Antimicrobial Susceptibility Test (Class II, 5 clearances)
• LKC — Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus (Class II)
• LKH — Antisera, Immunoperoxidase, Chlamydia Spp. (Class I, 8 clearances)
• LKI — Antisera, Fluorescent, Chlamydia Spp. (Class I, 6 clearances)
• LKQ — Antibody Igm,If, Cytomegalovirus Virus (Class II, 18 clearances)
• LKS — Device, Parasite Concentration (Class I, 13 clearances)
• LKT — Respiratory Syncytial Virus, Antigen, Antibody, Ifa (Class I, 23 clearances)
• LLA — Direct Agglutination Test, Toxoplasma Gondii (Class II, 4 clearances)
• LLH — Reagents, Clostridium Difficile Toxin (Class I, 42 clearances)
• LLM — Test, Antigen, Nuclear, Epstein-Barr Virus (Class I, 27 clearances)
• LOL — Hepatitis A Test (Antibody And Igm Antibody) (Class II, 26 clearances)
• LOM — Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) (Class II)
• LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II, 289 clearances)
• LOO — Reagent, Leishmanii Serological (Class I, 2 clearances)
• LOP — Solution, Antimicrobial (Class II, 3 clearances)
• LQF — Dna-Reagents, Mycobacterium Spp. (Class I, 15 clearances)
• LQG — Dna-Reagents, Mycoplasma Spp. (Class I, 1 clearances)
• LQH — Dna-Reagents, Legionella (Class II, 2 clearances)
• LQI — Hepatitis Delta Serological Reagents (Class III)
• LQL — Gram Positive Identification Panel (Class I, 11 clearances)
• LQM — Gram Negative Identification Panel (Class I, 7 clearances)
• LQN — Latex Agglutination Assay, Rubella (Class II, 13 clearances)
• LQO — Dna-Reagents, Campylobacter Spp. (Class I, 4 clearances)
• LQP — Campylobacter Spp. (Class I, 12 clearances)
• LRF — Candida Spp., Direct Antigen, Id (Class II, 3 clearances)
• LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II, 45 clearances)
• LRH — Instrument For Auto Reader Of Overnight Microorganism Identification System (Class I, 4 clearances)
• LSC — Neisseria Controls (Class I, 7 clearances)
• LSD — Rubella, Other Assays (Class II)
• LSE — Epstein-Barr Virus, Other (Class I, 56 clearances)
• LSF — Dna-Reagents, Epstein-Barr Virus (Class I)
• LSG — Candida Species, Antibody Detection (Class II)
• LSH — Antigen, Blastomyces Dermatitidis, Other (Class II)
• LSI — Antiserum, Blastomyces Dermatitidis, Other (Class II)
• LSJ — Antigen, Rubella, Other (Class II)
• LSK — Dna-Reagents, Chlamydia (Class I, 8 clearances)
• LSL — Dna-Reagents, Neisseria (Class II, 45 clearances)
• LSM — Dna-Reagents, Salmonella Spp. (Class II)
• LSN — Dna-Reagents, Shigella Spp. (Class II)
• LSO — Dna-Reagents, Cytomegalovirus (Class II)
• LSQ — Reagent, Rickettsia Serological (Class I, 4 clearances)
• LSR — Reagent, Borrelia Serological Reagent (Class II, 111 clearances)
• LTS — Test Reagents, Neisseria Gonorrhoeae Biochemical (Class I, 1 clearances)
• LTT — Panels, Test, Susceptibility, Antimicrobial (Class II, 50 clearances)
• LTW — Susceptibility Test Cards, Antimicrobial (Class II, 16 clearances)
• LTX — Discs, Elution (Class II, 2 clearances)
• LYF — Pneumocystis Carinii (Class II, 7 clearances)
• LYR — Helicobacter Pylori (Class I, 91 clearances)
• MAQ — Kit, Dna Detection, Human Papillomavirus (Class III)
• MBT — Dna-Probe, Reagent, Histoplasma Capsulatum (Class II, 1 clearances)
• MCB — Antigen, C. Difficile (Class I, 10 clearances)
• MCC — Dna-Probe, Haemophilus Spp. (Class II, 2 clearances)
• MCD — Antigen, Ebv, Capsid (Class I, 8 clearances)
• MCE — Respiratory Syncytial Virus - Elisa (Class I, 2 clearances)
• MCG — Dna-Probe, Agent, Listeria (Class I)
• MCS — Dna-Probe, Staphylococcus Aureus (Class I, 1 clearances)
• MCT — Dna-Probe, Strep Pneumoniae (Class I, 1 clearances)
• MDB — System, Blood Culturing (Class I, 67 clearances)
• MDC — Dna-Probe - Blastomyces Dermatitidis (Class II, 1 clearances)
• MDE — Dna-Probe, Reagents, Cryptococcal (Class II, 1 clearances)
• MDF — Dna-Probe, Reagents, Coccidioides Immitis (Class II, 1 clearances)
• MDJ — Reagents, Cysticercosis (Class I, 1 clearances)
• MDK — Dna-Probe, Reagents, Streptococcal (Class I, 4 clearances)
• MDT — Elisa, Trichinella Spiralis (Class I)
• MDU — Antigen, Elisa, Cryptococcus (Class II, 2 clearances)
• MGM — C. Trachomatis (Chlamydia Group) (Class I)
• MHI — Giardia Spp. (Class II, 27 clearances)
• MHJ — Cryptosporidium Spp. (Class II, 15 clearances)
• MHR — Test, Anti-Tumor Cell Susceptibility (Class III)
• MIU — Enzyme Linked Immunosorbent Assay, T. Cruzi (Class I, 6 clearances)
• MIV — Immunofluorescent Assay, T. Cruzi (Class I)
• MIY — Enzyme Linked Immunosorbent Assay, Coccidioides Immitis (Class II, 1 clearances)
• MIZ — Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum (Class II, 2 clearances)
• MJA — Susceptibility Test Powders, Antimycobacterial (Class II, 5 clearances)
• MJD — Culture Media, Antimycobacteria, Susceptibility Test (Class II, 3 clearances)
• MJE — Culture Media, Antifungal, Susceptibility Test (Class II, 1 clearances)
• MJH — Legionella, Spp., Elisa (Class II, 10 clearances)
• MJK — Dna Probe, Trichomonas Vaginalis (Class I, 1 clearances)
• MJL — Eia, Blastomyces Dermatitidis (Class II, 2 clearances)
• MJM — Dna Probe, Gardnerella Vaginalis (Class I, 2 clearances)
• MJX — Kit, Serological, Positive Control (Class I, 7 clearances)
• MJY — Kit, Serological, Negative Control (Class I, 1 clearances)
• MJZ — Kit, Direct Antigen, Positive Control (Class I, 3 clearances)
• MKA — Kit, Direct Antigen, Negative Control (Class I)
• MKT — Hepatitis Viral B Dna Detection (Class II)
• MKZ — Dna Probe, Nucleic Acid Amplification, Chlamydia (Class I, 19 clearances)
• MLA — Dna Probe, Yeast (Class I, 2 clearances)
• MSQ — Test, Urea (Breath Or Blood) (Class I, 17 clearances)
• MWA — System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex (Class II)
• MXJ — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II, 20 clearances)
• MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (Class II, 10 clearances)
• MYI — System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (Class II, 10 clearances)
• MYL — Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg (Class III)
• MYM — Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm (Class III)
• MZF — Test, Hiv Detection (Class II)
• MZO — Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus (Class II, 2 clearances)
• MZP — Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus (Class II, 4 clearances)
• NCD — Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis (Class III)
• NDZ — Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis (Class I, 1 clearances)
• NGS — Assay, Endotoxin Activity, Chemiluminescent (Class II, 2 clearances)
• NGZ — Susceptibility Test Plate, Antifungal (Class II, 21 clearances)
• NHT — Assay, Nucleic Acid Amplification, Bacillus Anthracis (Class II, 6 clearances)
• NHY — Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus (Class I)
• NHZ — Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus (Class I)
• NIA — Assay, Direct, Nucleic Acid Amplification, Influenza Virus (Class I)
• NIJ — System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (Class II, 6 clearances)
• NJO — System, Mycolic Acid Analysis, Mycobacterium Tuberculosis (Class I, 1 clearances)
• NJR — Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (Class I, 18 clearances)
• NOM — Antigen, Galactomannan, Aspergillus Spp. (Class I, 4 clearances)
• NOP — Elisa, Antibody, West Nile Virus (Class II, 10 clearances)
• NPO — Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody (Class II, 1 clearances)
• NQX — System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (Class II, 24 clearances)
• NQZ — Antigen, Invasive Fungal Pathogens (Class II, 2 clearances)
• NRL — Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis (Class II, 1 clearances)
• NTM — Antigen, Inflammatory Response Marker, Sepsis (Class II, 3 clearances)
• NVQ — Bacteriophage And Controls, B. Anthracis Lysis (Class II, 2 clearances)
• NWY — Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies (Not classified)
• NWZ — Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids (Class II, 1 clearances)
• NXD — Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna (Class II, 3 clearances)
• NXX — Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus (Class I, 4 clearances)
• NZS — Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast (Class I, 3 clearances)
• OAH — Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis (Class I, 4 clearances)
• OAI — Assay, Enterovirus Nucleic Acid (Class II, 2 clearances)
• OAX — Plasmodium Spp. Detection Reagents (Class II, 1 clearances)
• OBF — Assay, Genotyping, Hepatitis C Virus (Class II)
• OCC — Respiratory Virus Panel Nucleic Acid Assay System (Class II, 79 clearances)
• OEH — Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit (Class II, 2 clearances)
• OEM — Human Metapneumovirus (Hmpv) Rna Assay System (Class II, 6 clearances)
• OEP — Influenza A Virus Subtype Differentiation Nucleic Acid Assay (Class II, 1 clearances)
• OIH — Yersinia Spp. Reagents (Unclassified, 1 clearances)
• OJN — Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test (Class III)
• OJO — Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria (Not classified)
• OJY — Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers (Class II, 1 clearances)
• OMG — Antisera, Fluorescent, Human Metapneumovirus (Class II, 4 clearances)
• OMI — Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv (Class II, 2 clearances)
• OMN — C. Difficile Nucleic Acid Amplification Test Assay (Class I, 5 clearances)
• OMS — Novel Influenza A Virus, A/H5 Ns1 Protein (Class II, 1 clearances)
• OOU — Parainfluenza Multiplex Nucleic Acid Assay (Class II, 5 clearances)
• OPL — Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus (Class II, 3 clearances)
• OPM — Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 (Class II, 1 clearances)
• OQO — Herpes Simplex Virus Nucleic Acid Amplification Assay (Class II, 12 clearances)
• OQW — 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification (Class II, 10 clearances)
• ORL — Whole Blood Pre-Treatment T-Cell Enrichment Reagent (Class III)
• OSU — Dengue Serological Reagents (Class II, 1 clearances)
• OTG — Non-Sars Coronavirus Multiplex Nucleic Acid Assay (Class II)
• OTT — Research Use Only/Microbiology (Not classified)
• OUC — Norovirus Serological Reagent (Class II, 1 clearances)
• OUS — Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt (Class I, 2 clearances)
• OUY — Trichomonas Vaginalis Nucleic Acid Amplification Test System (Class II, 10 clearances)
• OUZ — Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids (Class I, 1 clearances)
• OVF — Assay, Direct, Nucleic Acid Amplification, Q Fever (Class I, 1 clearances)
• OWF — Immunohistochemical Assay, Helicobacter Pylori (Class I, 1 clearances)
• OYB — Kit, Rna Detection, Human Papillomavirus (Class III)
• OYP — Anti-Jcv Antibody Detection Assay (Class II, 2 clearances)
• OYZ — Group A Streptococcus Nucleic Acid Amplification Assay System (Class I, 1 clearances)
• OZA — Test, Urea Adult And Pediatric (Breath), (Class III)
• OZB — Dengue Nucleic Acid Amplification Assay (Naat) (Class II, 1 clearances)
• OZE — Influenza A And Influenza B Multiplex Nucleic Acid Assay (Class II, 20 clearances)
• OZN — C. Difficile Toxin Gene Amplification Assay (Class II, 17 clearances)
• OZX — Mycoplasma Pneumoniae Dna Assay System (Class II, 3 clearances)
• OZY — Chlamydophila Pneumoniae Dna Assay System (Class II)
• OZZ — Bordetella Pertussis Dna Assay System (Class II, 9 clearances)
• PAB — Cytomegalovirus (Cmv) Dna Quantitative Assay (Class II, 3 clearances)
• PAM — Gram-Positive Bacteria And Their Resistance Markers (Class II, 6 clearances)
• PBK — Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set (Class II, 5 clearances)
• PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System (Class II, 37 clearances)
• PCI — Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System (Class II, 5 clearances)
• PCL — Enzyme Linked Immunoabsorbent Assay, Rubeola Igm (Class I, 1 clearances)
• PCY — Investigational Use Only - Microbiology (Not classified)
• PEN — Gram-Negative Bacteria And Associated Resistance Markers (Class II, 11 clearances)
• PEO — Fungal Organisms, Nucleic Acid-Based Assay (Class II, 2 clearances)
• PEU — System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen (Class II, 2 clearances)
• PEX — System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (Class II, 5 clearances)
• PGH — Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel (Class II, 3 clearances)
• PGI — Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (Class II, 9 clearances)
• PGX — Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System (Class II, 13 clearances)
• PII — Candida Species Nucleic Acid Detection System (Class II, 3 clearances)
• PIQ — Reagents For Detection Of Norovirus Nucleic Acid (Class II, 1 clearances)
• PIT — Leishmania Spp. Antigen Detection Assay (Class I, 1 clearances)
• PLO — Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System (Class II, 4 clearances)
• PMN — Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays (Class II, 30 clearances)
• PMT — Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens (Class II, 5 clearances)
• PMY — System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony (Class II, 3 clearances)
• POA — Reagents, Zika Virus Nucleic Acid (Not classified)
• POC — System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen (Class II, 3 clearances)
• POG — Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid (Not classified)
• PPU — Microbial Colony Image Assessment System (Class II, 3 clearances)
• PQA — Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (Class II, 11 clearances)
• PQQ — Data Acquisition Software (Class II)
• PQZ — Gbs Culture Media, Selective And Differential (Class I, 4 clearances)
• PRA — Variola Virus Nucleic Acid-Based Detection Assay (Class II, 1 clearances)
• PRE — Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers (Class II, 4 clearances)
• PRH — Positive Blood Culture Identification And Ast Kit (Class II, 2 clearances)
• PRI — Procalcitonin Assay (Class II, 8 clearances)
• PSZ — Devices Detecting Influenza A, B, And C Virus Antigens (Class II, 72 clearances)
• PTF — Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission (Class II, 4 clearances)
• PTJ — Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates (Class II, 3 clearances)
• PUQ — Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm (Class II, 1 clearances)
• PVQ — Rickettsia Spp. Nucleic Acid Based Detection Assay (Class II, 1 clearances)
• PYN — Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. (Class II, 1 clearances)
• PYS — Zika Virus Serological Reagents (Emergency Use) (Not classified)
• PZF — Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System (Class II, 1 clearances)
• QAA — Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens (Class II, 1 clearances)
• QBD — Microbial Nucleic Acid Storage And Stabilization Device (Class II, 17 clearances)
• QBH — Lower Respiratory Microbial Nucleic Acid Detection System (Class II, 2 clearances)
• QBN — Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (Class II, 4 clearances)
• QBQ — System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture (Class I, 1 clearances)
• QBX — Direct Blood Bacterial Nucleic Acid Detection System (Class II, 2 clearances)
• QCH — Assayed Quality Control Material For Clinical Microbiology Assays (Class II, 1 clearances)
• QCU — Dengue Virus Antigen Assay (Class II, 1 clearances)
• QDP — Respiratory Panel (Class II, 2 clearances)
• QDS — Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System (Class II, 3 clearances)
• QDZ — Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection (Class II, 2 clearances)
• QEP — Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections (Class II, 21 clearances)
• QFA — Assay For Detection Of Proteases In Chronic Wounds (Class II, 1 clearances)
• QFO — Zika Virus Serological Reagents (Class II, 4 clearances)
• QFS — Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment (Class II, 1 clearances)
• QGN — Lateral Flow Immunochromatography Assay For Host Infection Biomarkers (Class II, 2 clearances)
• QHM — Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations (Unclassified)
• QHO — Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations (Unclassified)
• QHV — Multiple Osteoarticular Pathogen Antigen Kit (Not classified)
• QIC — Hiv-1 Genotyping Assay Using Ngs Technology (Class II)
• QID — Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens (Class II, 1 clearances)
• QIM — Bartonella Spp. Serological Reagents (Not classified)
• QIN — Babesia Spp. Serological Reagents (Not classified)
• QIO — Anaplasma Spp. And Ehrlichia Spp. Serological Reagents (Not classified)
• QIP — Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents (Not classified)
• QIQ — Orientia Spp. (Scrub Typhus) Serological Reagents (Not classified)
• QIV — Culture-Based Short-Term Incubation Antimicrobial Resistance Assay (Class II, 1 clearances)
• QJR — Reagents, 2019-Novel Coronavirus Nucleic Acid (Not classified)
• QKO — Reagent, Coronavirus Serological (Not classified)
• QKP — Coronavirus Antigen Detection Test System. (Not classified)
• QLT — Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices (Not classified)
• QLW — Covid-19 Test Home Collection Kit Devices (Not classified)
• QLX — Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna (Class II, 4 clearances)
• QMC — Transport Medium, Notified Per The Vtm Guidance (Class I)
• QMI — Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna (Class II, 2 clearances)
• QMN — Covid-19 Multi-Analyte Antigen Device (Not classified)
• QMV — Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness (Class II, 3 clearances)
• QNJ — Mass Spectrometry, Microorganism Identification, Blood Culture (Class II, 2 clearances)
• QOF — Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents (Class II, 32 clearances)
• QPO — Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples (Class II, 1 clearances)
• QPS — Immunoassay For Host Biomarkers Of Infection (Class II, 4 clearances)
• QQV — Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry (Class II, 4 clearances)
• QQX — Respiratory Specimen Nucleic Acid Sars-Cov-2 Test (Class II, 11 clearances)
• QQY — Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms (Class II, 2 clearances)
• QSH — Coronavirus Marker Detection (Not classified)
• QSN — Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System (Class II, 1 clearances)
• QSS — Hiv Self-Tests (Class III)
• QST — Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test (Class II)
• QSU — Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test (Class II)
• QSV — Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test (Class II)
• QTA — Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis (Not classified)
• QTM — Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening. (Class II)
• QTP — Reagents, Monkeypox Virus Nucleic Acid. (Not classified)
• QTQ — Reagents, Non-Variola Orthopoxvirus Nucleic Acid. (Not classified)
• QTU — Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests (Not classified)
• QUT — Deformability Cytometry For Sepsis Risk Assessment (Class II, 3 clearances)
• QUU — Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples (Class II, 2 clearances)
• QVF — Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings (Class II, 8 clearances)
• QVP — Sars-Cov-2 Serology Test (Class II, 5 clearances)
• QVR — Multiplex Nucleic Acid Detection System For Biothreat Agents (Class II, 2 clearances)
• QWB — Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens (Class II, 2 clearances)
• QWR — Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings (Class II, 3 clearances)
• QXA — Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection (Class II, 2 clearances)
• QYA — System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home (Class II, 2 clearances)
• QYT — Over-The-Counter Covid-19 Antigen Test (Class II, 13 clearances)
• QZX — Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing (Class II, 3 clearances)
• SAD — Japanese Encephalitis Virus Immunological/Serology Test (Not classified)
• SAN — Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples (Class II, 6 clearances)
• SBP — Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test (Class II, 1 clearances)
• SBT — Device To Detect Microbial Colonization Directly From Clinical Specimens. (Class II, 1 clearances)
• SBZ — Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users (Class II, 1 clearances)
• SCA — Multi-Analyte Respiratory Virus Antigen Detection Test (Class II, 11 clearances)
• SCX — Immunoassay For Host Biomarkers Of Sepsis (Class II, 1 clearances)
• SDM — Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps (Unclassified)
• SDN — Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps (Unclassified)
• SEA — Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users (Class II, 1 clearances)
• SEI — Qualitative And Quantitative Hepatitis B Virus Antibody Assays (Class II, 4 clearances)
• SEP — Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay (Class II, 2 clearances)
• SGA — Biothreat Microbial Agent Nucleic Acid Detection Test (Class II, 2 clearances)
• SGW — Device To Detect Antibodies To Hepatitis D Virus (Class II, 1 clearances)
• SIA — Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test (Class II)
• SIH — Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay (Class II)