- AnesthesiologyReview Panel
- 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
- 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
- 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
- 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
- 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
- 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
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents2Product Code
- QPSImmunoassay For Host Biomarkers Of Infection2Product Code
- QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test2Product 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
- 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
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Page Type
- Product Code
- Definition
- A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.
- Physical State
- A closed system disposable pouch that contains all necessary reagents for sample preparation, reverse transcription, polymerase chain reaction (PCR), and detection from multiple respiratory pathogens from a single nasopharyngeal swab specimen. The reagent pouch is hydrated with sample buffer and specimen to activate and is placed into an automated instrument to perform the sample preparation, PCR reaction, and detection for result generation.
- Technical Method
- A nucleic acid amplification test (NAAT). PCR-based.
- Target Area
- Nasopharyngeal (i.e., upper respiratory) swab specimen.
- Regulation Medical Specialty
- Microbiology
- Review Panel
- Microbiology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.3981
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 866.3981 Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test
§ 866.3981 Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.
(a) Identification. A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) The intended use in the labeling required under § 809.10 of this chapter must include a description of the following: Analytes and targets the device detects and identifies, the specimen types tested, the results provided to the user, the clinical indications for which the test is to be used, the specific intended population(s), the intended use locations including testing location(s) where the device is to be used (if applicable), and other conditions of use as appropriate.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens;
(ii) Detailed descriptions of the performance characteristics of the device for each specimen type claimed in the intended use based on analytical studies including the following, as applicable: Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, precision, reproducibility, and clinical studies;
(iii) Detailed descriptions of the test procedure(s), the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing;
(iv) A warning statement that viral culture should not be attempted in cases of positive results for SARS-CoV-2 and/or any similar microbial agents unless a facility with an appropriate level of laboratory biosafety (e.g., BSL 3 and BSL 3+, etc.) is available to receive and culture specimens; and
(v) A prominent statement that device performance has not been established for specimens collected from individuals not identified in the intended use population (e.g., when applicable, that device performance has not been established in individuals without signs or symptoms of respiratory infection).
(vi) Limiting statements that indicate that:
(A) A negative test result does not preclude the possibility of infection;
(B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician;
(C) There is a risk of incorrect results due to the presence of nucleic acid sequence variants in the targeted pathogens;
(D) That positive and negative predictive values are highly dependent on prevalence;
(E) Accurate results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and
(F) When applicable (e.g., recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer-reviewed literature), that the clinical performance may be affected by testing a specific clinical subpopulation or for a specific claimed specimen type.
(4) Design verification and validation must include:
(i) Detailed documentation, including performance results, from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, as appropriate, additional characterized clinical samples. The clinical study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained using a comparator that FDA has determined is appropriate. Detailed documentation must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of all statistical analyses.
(ii) Risk analysis and documentation demonstrating how risk control measures are implemented to address device system hazards, such as Failure Modes Effects Analysis and/or Hazard Analysis. This documentation must include a detailed description of a protocol (including all procedures and methods) for the continuous monitoring, identification, and handling of genetic mutations and/or novel respiratory pathogen isolates or strains (e.g., regular review of published literature and periodic in silico analysis of target sequences to detect possible mismatches). All results of this protocol, including any findings, must be documented and must include any additional data analysis that is requested by FDA in response to any performance concerns identified under this section or identified by FDA during routine evaluation. Additionally, if requested by FDA, these evaluations must be submitted to FDA for FDA review within 48 hours of the request. Results that are reasonably interpreted to support the conclusion that novel respiratory pathogen strains or isolates impact the stated expected performance of the device must be sent to FDA immediately.
(iii) A detailed description of the identity, phylogenetic relationship, and other recognized characterization of the respiratory pathogen(s) that the device is designed to detect. In addition, detailed documentation describing how to interpret the device results and other measures that might be needed for a laboratory diagnosis of respiratory infection.
(iv) A detailed device description, including device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including molecular target(s) for each analyte, design of target detection reagents, rationale for target selection, limiting factors of the device (e.g., saturation level of hybridization and maximum amplification and detection cycle number, etc.), internal and external controls, and computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported signal and result), as applicable.
(v) A detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review.
(vi) For devices intended for the detection and identification of microbial agents for which an FDA recommended reference panel is available, design verification and validation must include the performance results of an analytical study testing the FDA recommended reference panel of characterized samples. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(vii) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens, the design verification and validation must include a detailed description of the identity, phylogenetic relationship, or other recognized characterization of the Influenza A and B viruses that the device is designed to detect, a description of how the device results might be used in a diagnostic algorithm and other measures that might be needed for a laboratory identification of Influenza A or B virus and of specific Influenza A virus subtypes, and a description of the clinical and epidemiological parameters that are relevant to a patient case diagnosis of Influenza A or B and of specific Influenza A virus subtypes. An evaluation of the device compared to a currently appropriate and FDA accepted comparator method. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(5) When applicable, performance results of the analytical study testing the FDA recommended reference panel described in paragraph (b)(4)(vi) of this section must be included in the device's labeling under § 809.10(b) of this chapter.
(6) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens in addition to detection of SARS-CoV-2 and similar microbial agents, the required labeling under § 809.10(b) of this chapter must include the following:
(i) Where applicable, a limiting statement that performance characteristics for Influenza A were established when Influenza A/H3 and A/H1-2009 (or other pertinent Influenza A subtypes) were the predominant Influenza A viruses in circulation.
(ii) Where applicable, a warning statement that reads if infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to State or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
(iii) Where the device results interpretation involves combining the outputs of several targets to get the final results, such as a device that both detects Influenza A and differentiates all known Influenza A subtypes that are currently circulating, the device's labeling must include a clear interpretation instruction for all valid and invalid output combinations, and recommendations for any required followup actions or retesting in the case of an unusual or unexpected device result.
(iv) A limiting statement that if a specimen yields a positive result for Influenza A, but produces negative test results for all specific influenza A subtypes intended to be differentiated (i.e., H1-2009 and H3), this result requires notification of appropriate local, State, or Federal public health authorities to determine necessary measures for verification and to further determine whether the specimen represents a novel strain of Influenza A.
(7) If one of the actions listed at section 564(b)(1)(A) through (D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those influenza viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized influenza viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's labeling required under § 809.10(b) of this chapter that accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that accompanies the device, prominently providing a hyperlink to the manufacturer's public website where the analytical reactivity testing data can be found. The manufacturer's website, as well as the primary part of the manufacturer's website that discusses the device, must provide a prominently placed hyperlink to the website containing this information and must allow unrestricted viewing access.
[89 FR 66554, Aug. 16, 2024]