Anesthesiology
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- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- GOHAntigens, Cf (Including Cf Control), Poliovirus 1-31Product Code
- GOIAntiserum, Fluorescent, Rabies Virus2Product Code
- GOJAntisera, Neutralization, Rubella2Product Code
- GOKAntisera, Hai (Including Hai Control), Rubella2Product Code
- GOLAntigen, Ha (Including Ha Control), Rubella2Product Code
- GOMAntisera, Cf, Rubella2Product Code
- GONAntigen, Cf (Including Cf Control), Rubella2Product Code
- GOOAntisera, Fluorescent, All Globulins, Salmonella Spp.2Product Code
- GOPAntisera, C. Acnes (553, 605)1Product Code
- GOSAntiserum, Fluorescent, C. Diphtheriae1Product Code
- GOTAntigen, B. Parapertussis1Product Code
- GOWAntisera, Agglutinating, B. Parapertussis1Product Code
- GOXAntigen, B. Pertussis1Product Code
- GOYAntisera, Agglutinating, B. Pertussis, All1Product Code
- GOZAntisera, Fluorescent, B. Pertussis1Product Code
- OUYTrichomonas Vaginalis Nucleic Acid Amplification Test System2Product Code
- GODAntigens, Cf (Including Cf Control), Adenovirus 1-331Product Code
- GOEAntisera, Fluorescent, Poliovirus 1-31Product Code
- GOFAntisera, Neutralization, Poliovirus 1-31Product Code
- GOGAntisera, Cf, Poliovirus 1-31Product Code
- QICHiv-1 Genotyping Assay Using Ngs Technology2Product Code
- GLZAntigens, If, Toxoplasma Gondii2Product Code
- GMAAntisera, Fluorescent, Sporothrix Schenekii1Product Code
- GMDAntisera, Latex Agglutination, Cryptococcus Neoformans2Product Code
- GMEAntisera, Fluorescent, Cryptococcus Neoformans2Product Code
- GMGAntigen, Latex Agglutination, Coccidioides Immitis2Product Code
- GMHAntiserum, Positive Control, Coccidioides Immitis2Product Code
- GMIAntigen, Cf And / Or Id, Coccidioides Immitis2Product Code
- GMJAntigens, Histoplasma Capsulatum, All2Product Code
- GMKAntiserum, Positive Control, Histoplasma Capsulatum2Product Code
- GMLAntisera, Fluorescent, Histoplasma Capsulatum2Product Code
- GMMAntigens, Iha, Toxoplasma Gondii2Product Code
- GMNAntigens, Cf, Toxoplasma Gondii2Product Code
- GMOAntigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.2Product Code
- GMPAntisera, Control For Nontreponemal Tests2Product Code
- GMQAntigens, Nontreponemal, All2Product Code
- GMRSera, Reactive And Non-Specific Control, Fta-Abs Test2Product Code
- GMSAnti-Human Globulin, Fta-Abs Test2Product Code
- GMTAntigens, Ha, Treponema Pallidum2Product Code
- GMWTest, Sorbent, Fta-Abs2Product Code
- GMXAntisera, Fluorescent Antibody For Fta-Abs Test2Product Code
- GMYAntisera, Fluorescent, All Types, Escherichia Coli1Product Code
- GMZAntigens, All Types, Escherichia Coli1Product Code
- GNAAntisera, All Types, Escherichia Coli1Product Code
- GNBAntisera, All Types, Shigella Spp.2Product Code
- GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.2Product Code
- GNDAntigen, Iha, T. Cruzi1Product Code
- GNEAntigen, Latex Agglutination, T. Cruzi1Product Code
- GNFAntigen, Cf, T. Cruzi1Product Code
- GNGAntigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-61Product Code
- GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni1Product Code
- GNIAntisera, Neutralization, Echovirus 1-341Product Code
- GNJAntigens, Ha, Echovirus 1-341Product Code
- GNKAntisera, Cf, Echovirus 1-341Product Code
- GNLAntigens, Cf (Including Cf Control), Echovirus 1-341Product Code
- GNMAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-61Product Code
- GNNAntisera, Neutralization, Coxsackievirus A 1-24, B 1-61Product Code
- GNOAntisera, Cf, Coxsackievirus A 1-24, B 1-61Product Code
- GNPAntiserum, Cf, Epstein-Barr Virus1Product Code
- GNQAntigen, Cf (Including Cf Control), Epstein-Barr Virus1Product Code
- GNRAntisera, Neutralization, Influenza Virus A, B, C1Product Code
- GNSAntisera, Hai, Influenza Virus A, B, C1Product Code
- GNTAntigens, Ha (Including Ha Control), Influenza Virus A, B, C1Product Code
- GNWAntisera, Cf, Influenza Virus A, B, C1Product Code
- GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C1Product Code
- GNYAntisera, Fluorescent, Adenovirus 1-331Product Code
- GNZAntisera, Neutralization, Adenovirus 1-331Product Code
- GOAAntisera, Cf, Adenovirus 1-331Product Code
- GOBAntigens, Ha (Including Ha Control), Adenovirus 1-331Product Code
- GOCAntisera, Hai, Adenovirus 1-331Product Code
- GPDAntigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus1Product Code
- GPEAntisera, Positive Control, Echinococcus Spp.1Product Code
- GPFAntigen, Agglutinating, Echinococcus Spp.1Product Code
- GPGAntigen, Latex Agglutination, Trichinella Spiralis1Product Code
- GPHAntiserum, Bentonite Flocculation, Trichinella Spiralis1Product Code
- GPIAntigen, Bentonite Flocculation, Trichinella Spiralis1Product Code
- GPJAntiserum, Fluorescent, Q Fever1Product Code
- GPKAntiserum, Rickettsial Pox1Product Code
- GPMAntiserum, Murine Typhus Fever1Product Code
- GPNAntiserum, Typhus Fever1Product Code
- GPOAntigen, Cf, Typhus Fever Group1Product Code
- GPPAntiserum, Rocky Mountain Spotted Fever1Product Code
- GPQAntigen, Cf, Spotted Fever Group1Product Code
- GPRAntiserum, Cf, Q Fever1Product Code
- GPSAntigen, Cf, Q Fever1Product Code
- GPTAntiserum, Cf, Psittacosis (Chlamydia Group)1Product Code
- GPWAntigen, Cf, Psittacosis (Chlamydia Group)1Product Code
- GPXAntisera, Neutralizion, Reovirus 1-31Product Code
- GPYAntisera, Hai, Reovirus 1-31Product Code
- GPZAntisera, Cf, Reovirus 1-31Product Code
- GQAAntigens, Ha (Including Ha Control), Reovirus 1-31Product Code
- GQBAntigens, Cf (Including Cf Control), Reovirus 1-31Product Code
- GQCAntisera, Cf, Equine Encephalitis Virus, Eee, Wee1Product Code
- GQDAntigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee1Product Code
- GQEAntisera, Neutralization, All Types, Rhinovirus1Product Code
- GQFAntiserum, Neutralization, Respiratory Syncytial Virus1Product Code
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus1Product Code
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus2Product Code
- GQIAntiserum, Cf, Cytomegalovirus2Product Code
- GQJAntiserum, Cf, Lymphocytic Choriomeningitis Virus1Product Code
- GQKAntigen, Cf, Lymphocytic Choriomeningitis Virus1Product Code
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,22Product Code
- GQMAntisera, Neutralization, Herpesvirus Hominis2Product Code
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,22Product Code
- GQOAntisera, Cf, Herpesvirus Hominis 1,22Product Code
- GQPAntisera, Neutralization, Parainfluenza Virus 1-41Product Code
- GQQAntisera, Hai, Parainfluenza Virus 1-41Product Code
- GQRAntigens, Ha (Including Ha Control), Parainfluenza Virus 1-41Product Code
- GQSAntigens, Cf (Including Cf Control), Parainfluenza Virus 1-41Product Code
- GQTAntisera, Cf, Parainfluenza Virus 1-41Product Code
- GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster2Product Code
- GQXAntiserum, Cf, Varicella-Zoster2Product Code
- GQYAntigen, Ha (Including Ha Control), Mumps Virus1Product Code
- GQZAntiserum, Neutralization, Mumps Virus1Product Code
- GRAAntiserum, Fluorescent, Mumps Virus1Product Code
- GRBAntiserum, Cf, Mumps Virus1Product Code
- GRCAntigen, Cf (Including Cf Control), Mumps Virus1Product Code
- GRDAntiserum, Hai, Mumps Virus1Product Code
- GREAntiserum, Fluorescent, Rubeola1Product Code
- GRFAntiserum, Cf, Rubeola1Product Code
- GRGAntiserum, Hai, Rubeola1Product Code
- GRHAntigen, Ha (Including Ha Control), Rubeola1Product Code
- GRIAntiserum, Neutralization, Rubeola1Product Code
- GRJAntigen, Cf, (Including Cf Control), Rubeola1Product Code
- GRKAntisera, Fluorescent, Echovirus 1-341Product Code
- GRLAntigens, All Groups, Salmonella Spp.2Product Code
- GRMAntisera, All Groups, Salmonella Spp.2Product Code
- GROAntisera, Fluorescent, All Types, Hemophilus Spp.2Product Code
- GRPAntisera, All Types, H. Influenza2Product Code
- GRTAntiserum, Fluorescent, Mycobacterium Tuberculosis1Product Code
- GRWAntisera, All Fluorescent, Leptospira Spp.2Product Code
- GRXAntisera, All Leptospira Spp.2Product Code
- GRYAntigens, All, Leptospira Spp.2Product Code
- GRZAntisera, Fluorescent, All, Mycoplasma Spp.1Product Code
- GSAAntisera, All Mycoplasma Spp.1Product Code
- GSBAntigens, Cf, All, Mycoplasma Spp.1Product Code
- GSDAntiserum, Fluorescent, Erysipelothrix Rhusiopathiae1Product Code
- GSEAntiserum, Erysipelothrix Rhusiopathiae1Product Code
- GSFAntigen, Erysipelothrix Rhusiopathiae1Product Code
- GSGAntisera, Fluorescent, All Types, Listeria Monocytogenes1Product Code
- GSHAntisera, All Types, Listeria Monocytogenes1Product Code
- GSIAntigens, Slide And Tube, All Types, Listeria Monocytogenes1Product Code
- GSJAntiserum, Fluorescent, Francisella Tularensis2Product Code
- GSKAntiserum, Francisella Tularensis2Product Code
- GSLAntigens, Slide And Tube, Francisella Tularensis2Product Code
- GSMAntisera, Fluorescent, Brucella Spp.2Product Code
- GSNAntiserum, Positive And Negative Febrile Antigen Control Serum2Product Code
- GSOAntigens (Febrile), Agglutination, Brucella Spp.2Product Code
- GSPAntiserum, Fluorescent, Campylobacter Fetus1Product Code
- GSQAntiserum, Vibrio Cholerae, All Varieties2Product Code
- GSRAntisera, Fluorescent, Pseudomonas Pseudomallei2Product Code
- GSSAntisera, Fluorescent, Pseudomonas Aeruginosa2Product Code
- GSTAntiserum, Pseudomonas Pseudomallei2Product Code
- GSWAntiserum, Flavobacterium Meningosepticum, All Groups1Product Code
- GSXAntisera, Acinetobacter Calcoaceticus, All Varieties1Product Code
- GSYAntisera, Fluorescent, All Globulins, Proteus Spp.1Product Code
- GSZAntigens, Febrile (Weil-Felix), All Groups1Product Code
- GTAAntisera, All, Serratia Marcesans1Product Code
- GTBAntisera, Fluorescent, All Types, Klebsiella Spp.1Product Code
- GTCAntisera, All Types, Klebsiella Spp.1Product Code
- GTDAntisera, Fluorescent, All Globulins, Shigella Spp.2Product Code
- GTEAntisera, Arizona Spp., All1Product Code
- GTFAntisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.1Product Code
- GTHAntiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae2Product Code
- GTIAntisera, Fluorescent, All Groups, N. Meningitidis2Product Code
- GTJAntisera, All Groups, N. Meningitidis2Product Code
- GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.1Product Code
- GTOAnti-Streptokinase1Product Code
- GTPExoenzymes, Multiple, Streptococcal1Product Code
- GTQAntistreptolysin - Titer/Streptolysin O Reagent1Product Code
- GTRAntideoxyribonuclease, Streptococcus Spp.1Product Code
- GTXAntisera, Fluorescent, All Groups, Streptococcus Spp.1Product Code
- GTYAntigens, All Groups, Streptococcus Spp.1Product Code
- GTZAntisera, All Groups, Streptococcus Spp.1Product Code
- GWBAntisera, Fluorescent, All Types, Streptococcus Pneumoniae1Product Code
- GWCAntisera, All Types, Streptococcus Pneumoniae1Product Code
- GWDIndirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp2Product Code
- JRWAntisera, Fluorescent, B. Parapertussis1Product Code
- JRYAntiserum, Fluorescent, Epstein-Barr Virus1Product Code
- JWKAntigen, Positive Control, Cryptococcus Neoformans2Product Code
- JWLAntigen, Treponema Pallidum For Fta-Abs Test2Product Code
- JWTAntigen, Cf, Aspergillus Spp.1Product Code
- JWWAntigen, Cf, B. Dermatitidis2Product Code
- KFGAntiserum, Positive Control, Aspergillus Spp.1Product Code
- KFHAntiserum, Positive Control, Blastomyces Dermatitidis2Product Code
- KFIStrip, Virulence, Corynebacterium Diphtheriae1Product Code
- KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.2Product Code
- KLHAntisera, C. Acnes1Product Code
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella2Product Code
- LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster2Product Code
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus2Product Code
- LGBGonococcal Antibody Tests3Product Code
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific2Product Code
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii2Product Code
- LHJStaphylococcus Aureus Protein A Insoluble1Product Code
- LHKAntigen, Id, Candida Albicans2Product Code
- LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent2Product Code
- LHTStaphylococcus Aureus Somatic Antigens1Product Code
- LHWErythrocyte Suspension, Multi Species, Serological Reagent And Equipment1Product Code
- LIAAntigens, All Groups, Shigella Spp.2Product Code
- LICAntiserum, Coagglutination (Direct) Neisseria Gonorrhoeae2Product Code
- LINAntisera, Conjugated Fluorescent, Cytomegalovirus2Product Code
- LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum2Product Code
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus1Product Code
- LIRAntigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae2Product Code
- LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg1Product Code
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)1Product Code
- LJKAntisera, If, Toxoplasma Gondii2Product Code
- LJNAntibody Igm, If, Epstein-Barr Virus1Product Code
- LJOAntigen, Iha, Cytomegalovirus2Product Code
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis1Product Code
- LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus1Product Code
- LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.1Product Code
- LKCAntigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus2Product Code
- LKHAntisera, Immunoperoxidase, Chlamydia Spp.1Product Code
- LKIAntisera, Fluorescent, Chlamydia Spp.1Product Code
- LKQAntibody Igm,If, Cytomegalovirus Virus2Product Code
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa1Product Code
- LLADirect Agglutination Test, Toxoplasma Gondii2Product Code
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus1Product Code
- LOLHepatitis A Test (Antibody And Igm Antibody)2Product Code
- LOOReagent, Leishmanii Serological1Product Code
- LQFDna-Reagents, Mycobacterium Spp.1Product Code
- LQGDna-Reagents, Mycoplasma Spp.1Product Code
- LQHDna-Reagents, Legionella2Product Code
- LQNLatex Agglutination Assay, Rubella2Product Code
- LQODna-Reagents, Campylobacter Spp.1Product Code
- LQPCampylobacter Spp.1Product Code
- LRFCandida Spp., Direct Antigen, Id2Product Code
- LSDRubella, Other Assays2Product Code
- LSEEpstein-Barr Virus, Other1Product Code
- LSFDna-Reagents, Epstein-Barr Virus1Product Code
- LSGCandida Species, Antibody Detection2Product Code
- LSHAntigen, Blastomyces Dermatitidis, Other2Product Code
- LSIAntiserum, Blastomyces Dermatitidis, Other2Product Code
- LSJAntigen, Rubella, Other2Product Code
- LSKDna-Reagents, Chlamydia1Product Code
- LSLDna-Reagents, Neisseria2Product Code
- LSMDna-Reagents, Salmonella Spp.2Product Code
- LSNDna-Reagents, Shigella Spp.2Product Code
- LSODna-Reagents, Cytomegalovirus2Product Code
- LSQReagent, Rickettsia Serological1Product Code
- LSRReagent, Borrelia Serological Reagent2Product Code
- LYFPneumocystis Carinii2Product Code
- LYRHelicobacter Pylori1Product Code
- MBTDna-Probe, Reagent, Histoplasma Capsulatum2Product Code
- MCCDna-Probe, Haemophilus Spp.2Product Code
- MCDAntigen, Ebv, Capsid1Product Code
- MCERespiratory Syncytial Virus - Elisa1Product Code
- MCGDna-Probe, Agent, Listeria1Product Code
- MCSDna-Probe, Staphylococcus Aureus1Product Code
- MCTDna-Probe, Strep Pneumoniae1Product Code
- MDCDna-Probe - Blastomyces Dermatitidis2Product Code
- MDEDna-Probe, Reagents, Cryptococcal2Product Code
- MDFDna-Probe, Reagents, Coccidioides Immitis2Product Code
- MDJReagents, Cysticercosis1Product Code
- MDKDna-Probe, Reagents, Streptococcal1Product Code
- MDTElisa, Trichinella Spiralis1Product Code
- MDUAntigen, Elisa, Cryptococcus2Product Code
- MGMC. Trachomatis (Chlamydia Group)1Product Code
- MHIGiardia Spp.2Product Code
- MHJCryptosporidium Spp.2Product Code
- MIUEnzyme Linked Immunosorbent Assay, T. Cruzi1Product Code
- MIVImmunofluorescent Assay, T. Cruzi1Product Code
- MIYEnzyme Linked Immunosorbent Assay, Coccidioides Immitis2Product Code
- MIZEnzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum2Product Code
- MJHLegionella, Spp., Elisa2Product Code
- MJLEia, Blastomyces Dermatitidis2Product Code
- MKZDna Probe, Nucleic Acid Amplification, Chlamydia1Product Code
- MSQTest, Urea (Breath Or Blood)1Product Code
- MWASystem, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex2Product Code
- MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-12Product Code
- MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-22Product Code
- NDZAssay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis1Product Code
- NGSAssay, Endotoxin Activity, Chemiluminescent2Product Code
- NHTAssay, Nucleic Acid Amplification, Bacillus Anthracis2Product Code
- NHYAssay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus1Product Code
- NHZAssay, Direct, Nucleic Acid Amplification, Parainfluenza Virus1Product Code
- NIAAssay, Direct, Nucleic Acid Amplification, Influenza Virus1Product Code
- NJOSystem, Mycolic Acid Analysis, Mycobacterium Tuberculosis1Product Code
- NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test1Product Code
- NOMAntigen, Galactomannan, Aspergillus Spp.1Product Code
- NOPElisa, Antibody, West Nile Virus2Product Code
- NPOKit, Immunochromatographic, Bacillus Anthracis Differential Antibody2Product Code
- NQZAntigen, Invasive Fungal Pathogens2Product Code
- NRLEnzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis2Product Code
- NTMAntigen, Inflammatory Response Marker, Sepsis2Product Code
- NVQBacteriophage And Controls, B. Anthracis Lysis2Product Code
- NWZGas Chromatography, Bacillus Anthracis Membrane Fatty Acids2Product Code
- NXDNucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna2Product Code
- NXXFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus1Product Code
- OAHFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis1Product Code
- OAIAssay, Enterovirus Nucleic Acid2Product Code
- OAXPlasmodium Spp. Detection Reagents2Product Code
- OMSNovel Influenza A Virus, A/H5 Ns1 Protein2Product Code
- OOUParainfluenza Multiplex Nucleic Acid Assay2Product Code
- OCCRespiratory Virus Panel Nucleic Acid Assay System2Product Code
- OEHJoint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit2Product Code
- OEMHuman Metapneumovirus (Hmpv) Rna Assay System2Product Code
- OEPInfluenza A Virus Subtype Differentiation Nucleic Acid Assay2Product Code
- OJYDevice To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers2Product Code
- OMGAntisera, Fluorescent, Human Metapneumovirus2Product Code
- OMIMultiplex Flow Immunoassay, T. Gondii, Rubella And Cmv2Product Code
- QGNLateral Flow Immunochromatography Assay For Host Infection Biomarkers2Product Code
- OPLMultiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus2Product Code
- OPMMultiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 22Product Code
- OQOHerpes Simplex Virus Nucleic Acid Amplification Assay2Product Code
- OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification2Product Code
- OSUDengue Serological Reagents2Product Code
- OTGNon-Sars Coronavirus Multiplex Nucleic Acid Assay2Product Code
- OUCNorovirus Serological Reagent2Product Code
- OUZNucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids1Product Code
- OVFAssay, Direct, Nucleic Acid Amplification, Q Fever1Product Code
- OWFImmunohistochemical Assay, Helicobacter Pylori1Product Code
- OYPAnti-Jcv Antibody Detection Assay2Product Code
- OYZGroup A Streptococcus Nucleic Acid Amplification Assay System1Product Code
- OZATest, Urea Adult And Pediatric (Breath),3Product Code
- OZBDengue Nucleic Acid Amplification Assay (Naat)2Product Code
- OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay2Product Code
- OZNC. Difficile Toxin Gene Amplification Assay2Product Code
- OZXMycoplasma Pneumoniae Dna Assay System2Product Code
- OZYChlamydophila Pneumoniae Dna Assay System2Product Code
- OZZBordetella Pertussis Dna Assay System2Product Code
- PAMGram-Positive Bacteria And Their Resistance Markers2Product Code
- PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System2Product Code
- PCIGastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System2Product Code
- PCLEnzyme Linked Immunoabsorbent Assay, Rubeola Igm1Product Code
- PENGram-Negative Bacteria And Associated Resistance Markers2Product Code
- PEOFungal Organisms, Nucleic Acid-Based Assay2Product Code
- PEUSystem, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen2Product Code
- PEXSystem, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates2Product Code
- PGHHsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel2Product Code
- PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples2Product Code
- PIICandida Species Nucleic Acid Detection System2Product Code
- PIQReagents For Detection Of Norovirus Nucleic Acid2Product Code
- PITLeishmania Spp. Antigen Detection Assay1Product Code
- PLOMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System2Product Code
- PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays2Product Code
- PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens2Product Code
- PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System2Product Code
- QBHLower Respiratory Microbial Nucleic Acid Detection System2Product Code
- PRERt-Qpcr Assay For Mrna Transcript Immune Biomarkers2Product Code
- PRIProcalcitonin Assay2Product Code
- PSZDevices Detecting Influenza A, B, And C Virus Antigens2Product Code
- PTFAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission2Product Code
- PUQMultiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm2Product Code
- PYNFish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.2Product Code
- QAACoccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens2Product Code
- QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates2Product Code
- QBXDirect Blood Bacterial Nucleic Acid Detection System2Product Code
- QCHAssayed Quality Control Material For Clinical Microbiology Assays2Product Code
- QCUDengue Virus Antigen Assay2Product Code
- QDPRespiratory Panel2Product Code
- QDZQualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection2Product Code
- QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections2Product Code
- QFAAssay For Detection Of Proteases In Chronic Wounds2Product Code
- QFOZika Virus Serological Reagents2Product Code
- QFSMonocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment2Product Code
- QLXNucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna2Product Code
- QMINucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna2Product Code
- QMVDevice To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness2Product Code
- QNJMass Spectrometry, Microorganism Identification, Blood Culture2Product Code
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents2Product Code
- QPSImmunoassay For Host Biomarkers Of Infection2Product Code
- QQVAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry2Product Code
- QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test2Product Code
- PZFMers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System2Product Code
- QDSMers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System2Product Code
- QSTLab-Based Hiv Nat Diagnostic And/Or Supplemental Test2Product Code
- QSUPoint Of Care Hiv Serology Diagnostic And/Or Supplemental Test2Product Code
- QSVPoint Of Care Hiv Nat Diagnostic And/Or Supplemental Test2Product Code
- QTMAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.2Product Code
- QUTDeformability Cytometry For Sepsis Risk Assessment2Product Code
- QXALateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection2Product Code
- SCXImmunoassay For Host Biomarkers Of Sepsis2Product Code
- Subpart F—Immunological Test SystemsCFR Sub-Part
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
- Page Type
- Product Code
- Definition
- Intended for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of Herpes Simplex Virus (HSV) central nervous system (CNS) infection. This test is an aid in the diagnosis of HSV-1 and HSV-2 CNS infections in conjunction with other clinical and laboratory findings. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
- Physical State
- Reagent Assay Kit and Instrument
- Technical Method
- Real-time Polymerase Chain Reaction Assay
- Target Area
- Not Applicable, the device is an In vitro diagnostic device
- Regulation Medical Specialty
- Microbiology
- Review Panel
- Microbiology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.3307
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- Yes
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 866.3307 Herpes simplex virus nucleic acid-based assay for central nervous system infections
§ 866.3307 Herpes simplex virus nucleic acid-based assay for central nervous system infections.
(a) Identification. A herpes simplex virus nucleic acid-based assay for central nervous system infections is a qualitative in vitro diagnostic device intended for the detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) samples from patients suspected of Herpes Simplex Virus (HSV) infections of the central nervous system (CNS). This test is intended as an aid in the diagnosis of HSV-1 and HSV-2 infections of the CNS. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Design verification and validation must include:
(i) Detailed documentation for the device description, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including primer design and selection.
(ii) Detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (limit of detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carryover, and cross contamination. Documentation must include reagent and sample stability recommendations.
(iii) Detailed documentation from a clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to the results of two polymerase chain reaction methods followed by bidirectional sequencing.
(iv) Documentation of an appropriate end user device training program that will be offered as part of efforts to mitigate the risk of failure to correctly operate the instrument.
(v) Quality assurance protocols and detailed documentation for device software, including standalone software applications and hardware-based devices that incorporate software.
(2) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed explanation of the interpretation of results and acceptance criteria.
(ii) A limiting statement indicating that negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
[90 FR 27235, June 26, 2025]