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Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart C—Microbiology Devices
CFR Sub-Part
Subpart D—Serological Reagents
CFR Sub-Part
GOH
Antigens, Cf (Including Cf Control), Poliovirus 1-3
1
Product Code
GOI
Antiserum, Fluorescent, Rabies Virus
2
Product Code
GOJ
Antisera, Neutralization, Rubella
2
Product Code
GOK
Antisera, Hai (Including Hai Control), Rubella
2
Product Code
GOL
Antigen, Ha (Including Ha Control), Rubella
2
Product Code
GOM
Antisera, Cf, Rubella
2
Product Code
GON
Antigen, Cf (Including Cf Control), Rubella
2
Product Code
GOO
Antisera, Fluorescent, All Globulins, Salmonella Spp.
2
Product Code
GOP
Antisera, C. Acnes (553, 605)
1
Product Code
GOS
Antiserum, Fluorescent, C. Diphtheriae
1
Product Code
GOT
Antigen, B. Parapertussis
1
Product Code
GOW
Antisera, Agglutinating, B. Parapertussis
1
Product Code
GOX
Antigen, B. Pertussis
1
Product Code
GOY
Antisera, Agglutinating, B. Pertussis, All
1
Product Code
GOZ
Antisera, Fluorescent, B. Pertussis
1
Product Code
OUY
Trichomonas Vaginalis Nucleic Acid Amplification Test System
2
Product Code
GOD
Antigens, Cf (Including Cf Control), Adenovirus 1-33
1
Product Code
GOE
Antisera, Fluorescent, Poliovirus 1-3
1
Product Code
GOF
Antisera, Neutralization, Poliovirus 1-3
1
Product Code
GOG
Antisera, Cf, Poliovirus 1-3
1
Product Code
QIC
Hiv-1 Genotyping Assay Using Ngs Technology
2
Product Code
GLZ
Antigens, If, Toxoplasma Gondii
2
Product Code
GMA
Antisera, Fluorescent, Sporothrix Schenekii
1
Product Code
GMD
Antisera, Latex Agglutination, Cryptococcus Neoformans
2
Product Code
GME
Antisera, Fluorescent, Cryptococcus Neoformans
2
Product Code
GMG
Antigen, Latex Agglutination, Coccidioides Immitis
2
Product Code
GMH
Antiserum, Positive Control, Coccidioides Immitis
2
Product Code
GMI
Antigen, Cf And / Or Id, Coccidioides Immitis
2
Product Code
GMJ
Antigens, Histoplasma Capsulatum, All
2
Product Code
GMK
Antiserum, Positive Control, Histoplasma Capsulatum
2
Product Code
GML
Antisera, Fluorescent, Histoplasma Capsulatum
2
Product Code
GMM
Antigens, Iha, Toxoplasma Gondii
2
Product Code
GMN
Antigens, Cf, Toxoplasma Gondii
2
Product Code
GMO
Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.
2
Product Code
GMP
Antisera, Control For Nontreponemal Tests
2
Product Code
GMQ
Antigens, Nontreponemal, All
2
Product Code
GMR
Sera, Reactive And Non-Specific Control, Fta-Abs Test
2
Product Code
GMS
Anti-Human Globulin, Fta-Abs Test
2
Product Code
GMT
Antigens, Ha, Treponema Pallidum
2
Product Code
GMW
Test, Sorbent, Fta-Abs
2
Product Code
GMX
Antisera, Fluorescent Antibody For Fta-Abs Test
2
Product Code
GMY
Antisera, Fluorescent, All Types, Escherichia Coli
1
Product Code
GMZ
Antigens, All Types, Escherichia Coli
1
Product Code
GNA
Antisera, All Types, Escherichia Coli
1
Product Code
GNB
Antisera, All Types, Shigella Spp.
2
Product Code
GNC
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
2
Product Code
GND
Antigen, Iha, T. Cruzi
1
Product Code
GNE
Antigen, Latex Agglutination, T. Cruzi
1
Product Code
GNF
Antigen, Cf, T. Cruzi
1
Product Code
GNG
Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6
1
Product Code
GNH
Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
1
Product Code
GNI
Antisera, Neutralization, Echovirus 1-34
1
Product Code
GNJ
Antigens, Ha, Echovirus 1-34
1
Product Code
GNK
Antisera, Cf, Echovirus 1-34
1
Product Code
GNL
Antigens, Cf (Including Cf Control), Echovirus 1-34
1
Product Code
GNM
Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
1
Product Code
GNN
Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6
1
Product Code
GNO
Antisera, Cf, Coxsackievirus A 1-24, B 1-6
1
Product Code
GNP
Antiserum, Cf, Epstein-Barr Virus
1
Product Code
GNQ
Antigen, Cf (Including Cf Control), Epstein-Barr Virus
1
Product Code
GNR
Antisera, Neutralization, Influenza Virus A, B, C
1
Product Code
GNS
Antisera, Hai, Influenza Virus A, B, C
1
Product Code
GNT
Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
1
Product Code
GNW
Antisera, Cf, Influenza Virus A, B, C
1
Product Code
GNX
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
1
Product Code
GNY
Antisera, Fluorescent, Adenovirus 1-33
1
Product Code
GNZ
Antisera, Neutralization, Adenovirus 1-33
1
Product Code
GOA
Antisera, Cf, Adenovirus 1-33
1
Product Code
GOB
Antigens, Ha (Including Ha Control), Adenovirus 1-33
1
Product Code
GOC
Antisera, Hai, Adenovirus 1-33
1
Product Code
GPD
Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus
1
Product Code
GPE
Antisera, Positive Control, Echinococcus Spp.
1
Product Code
GPF
Antigen, Agglutinating, Echinococcus Spp.
1
Product Code
GPG
Antigen, Latex Agglutination, Trichinella Spiralis
1
Product Code
GPH
Antiserum, Bentonite Flocculation, Trichinella Spiralis
1
Product Code
GPI
Antigen, Bentonite Flocculation, Trichinella Spiralis
1
Product Code
GPJ
Antiserum, Fluorescent, Q Fever
1
Product Code
GPK
Antiserum, Rickettsial Pox
1
Product Code
GPM
Antiserum, Murine Typhus Fever
1
Product Code
GPN
Antiserum, Typhus Fever
1
Product Code
GPO
Antigen, Cf, Typhus Fever Group
1
Product Code
GPP
Antiserum, Rocky Mountain Spotted Fever
1
Product Code
GPQ
Antigen, Cf, Spotted Fever Group
1
Product Code
GPR
Antiserum, Cf, Q Fever
1
Product Code
GPS
Antigen, Cf, Q Fever
1
Product Code
GPT
Antiserum, Cf, Psittacosis (Chlamydia Group)
1
Product Code
GPW
Antigen, Cf, Psittacosis (Chlamydia Group)
1
Product Code
GPX
Antisera, Neutralizion, Reovirus 1-3
1
Product Code
GPY
Antisera, Hai, Reovirus 1-3
1
Product Code
GPZ
Antisera, Cf, Reovirus 1-3
1
Product Code
GQA
Antigens, Ha (Including Ha Control), Reovirus 1-3
1
Product Code
GQB
Antigens, Cf (Including Cf Control), Reovirus 1-3
1
Product Code
GQC
Antisera, Cf, Equine Encephalitis Virus, Eee, Wee
1
Product Code
GQD
Antigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee
1
Product Code
GQE
Antisera, Neutralization, All Types, Rhinovirus
1
Product Code
GQF
Antiserum, Neutralization, Respiratory Syncytial Virus
1
Product Code
GQG
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
1
Product Code
GQH
Antigen, Cf (Including Cf Control), Cytomegalovirus
2
Product Code
GQI
Antiserum, Cf, Cytomegalovirus
2
Product Code
GQJ
Antiserum, Cf, Lymphocytic Choriomeningitis Virus
1
Product Code
GQK
Antigen, Cf, Lymphocytic Choriomeningitis Virus
1
Product Code
GQL
Antisera, Fluorescent, Herpesvirus Hominis 1,2
2
Product Code
GQM
Antisera, Neutralization, Herpesvirus Hominis
2
Product Code
GQN
Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
2
Product Code
GQO
Antisera, Cf, Herpesvirus Hominis 1,2
2
Product Code
GQP
Antisera, Neutralization, Parainfluenza Virus 1-4
1
Product Code
GQQ
Antisera, Hai, Parainfluenza Virus 1-4
1
Product Code
GQR
Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4
1
Product Code
GQS
Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
1
Product Code
GQT
Antisera, Cf, Parainfluenza Virus 1-4
1
Product Code
GQW
Antigen, Cf, (Including Cf Control), Varicella-Zoster
2
Product Code
GQX
Antiserum, Cf, Varicella-Zoster
2
Product Code
GQY
Antigen, Ha (Including Ha Control), Mumps Virus
1
Product Code
GQZ
Antiserum, Neutralization, Mumps Virus
1
Product Code
GRA
Antiserum, Fluorescent, Mumps Virus
1
Product Code
GRB
Antiserum, Cf, Mumps Virus
1
Product Code
GRC
Antigen, Cf (Including Cf Control), Mumps Virus
1
Product Code
GRD
Antiserum, Hai, Mumps Virus
1
Product Code
GRE
Antiserum, Fluorescent, Rubeola
1
Product Code
GRF
Antiserum, Cf, Rubeola
1
Product Code
GRG
Antiserum, Hai, Rubeola
1
Product Code
GRH
Antigen, Ha (Including Ha Control), Rubeola
1
Product Code
GRI
Antiserum, Neutralization, Rubeola
1
Product Code
GRJ
Antigen, Cf, (Including Cf Control), Rubeola
1
Product Code
GRK
Antisera, Fluorescent, Echovirus 1-34
1
Product Code
GRL
Antigens, All Groups, Salmonella Spp.
2
Product Code
GRM
Antisera, All Groups, Salmonella Spp.
2
Product Code
GRO
Antisera, Fluorescent, All Types, Hemophilus Spp.
2
Product Code
GRP
Antisera, All Types, H. Influenza
2
Product Code
GRT
Antiserum, Fluorescent, Mycobacterium Tuberculosis
1
Product Code
GRW
Antisera, All Fluorescent, Leptospira Spp.
2
Product Code
GRX
Antisera, All Leptospira Spp.
2
Product Code
GRY
Antigens, All, Leptospira Spp.
2
Product Code
GRZ
Antisera, Fluorescent, All, Mycoplasma Spp.
1
Product Code
GSA
Antisera, All Mycoplasma Spp.
1
Product Code
GSB
Antigens, Cf, All, Mycoplasma Spp.
1
Product Code
GSD
Antiserum, Fluorescent, Erysipelothrix Rhusiopathiae
1
Product Code
GSE
Antiserum, Erysipelothrix Rhusiopathiae
1
Product Code
GSF
Antigen, Erysipelothrix Rhusiopathiae
1
Product Code
GSG
Antisera, Fluorescent, All Types, Listeria Monocytogenes
1
Product Code
GSH
Antisera, All Types, Listeria Monocytogenes
1
Product Code
GSI
Antigens, Slide And Tube, All Types, Listeria Monocytogenes
1
Product Code
GSJ
Antiserum, Fluorescent, Francisella Tularensis
2
Product Code
GSK
Antiserum, Francisella Tularensis
2
Product Code
GSL
Antigens, Slide And Tube, Francisella Tularensis
2
Product Code
GSM
Antisera, Fluorescent, Brucella Spp.
2
Product Code
GSN
Antiserum, Positive And Negative Febrile Antigen Control Serum
2
Product Code
GSO
Antigens (Febrile), Agglutination, Brucella Spp.
2
Product Code
GSP
Antiserum, Fluorescent, Campylobacter Fetus
1
Product Code
GSQ
Antiserum, Vibrio Cholerae, All Varieties
2
Product Code
GSR
Antisera, Fluorescent, Pseudomonas Pseudomallei
2
Product Code
GSS
Antisera, Fluorescent, Pseudomonas Aeruginosa
2
Product Code
GST
Antiserum, Pseudomonas Pseudomallei
2
Product Code
GSW
Antiserum, Flavobacterium Meningosepticum, All Groups
1
Product Code
GSX
Antisera, Acinetobacter Calcoaceticus, All Varieties
1
Product Code
GSY
Antisera, Fluorescent, All Globulins, Proteus Spp.
1
Product Code
GSZ
Antigens, Febrile (Weil-Felix), All Groups
1
Product Code
GTA
Antisera, All, Serratia Marcesans
1
Product Code
GTB
Antisera, Fluorescent, All Types, Klebsiella Spp.
1
Product Code
GTC
Antisera, All Types, Klebsiella Spp.
1
Product Code
GTD
Antisera, Fluorescent, All Globulins, Shigella Spp.
2
Product Code
GTE
Antisera, Arizona Spp., All
1
Product Code
GTF
Antisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.
1
Product Code
GTH
Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
2
Product Code
GTI
Antisera, Fluorescent, All Groups, N. Meningitidis
2
Product Code
GTJ
Antisera, All Groups, N. Meningitidis
2
Product Code
GTN
Antisera, Fluorescent, All Types, Staphylococcus Spp.
1
Product Code
GTO
Anti-Streptokinase
1
Product Code
GTP
Exoenzymes, Multiple, Streptococcal
1
Product Code
GTQ
Antistreptolysin - Titer/Streptolysin O Reagent
1
Product Code
GTR
Antideoxyribonuclease, Streptococcus Spp.
1
Product Code
GTX
Antisera, Fluorescent, All Groups, Streptococcus Spp.
1
Product Code
GTY
Antigens, All Groups, Streptococcus Spp.
1
Product Code
GTZ
Antisera, All Groups, Streptococcus Spp.
1
Product Code
GWB
Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
1
Product Code
GWC
Antisera, All Types, Streptococcus Pneumoniae
1
Product Code
GWD
Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
2
Product Code
JRW
Antisera, Fluorescent, B. Parapertussis
1
Product Code
JRY
Antiserum, Fluorescent, Epstein-Barr Virus
1
Product Code
JWK
Antigen, Positive Control, Cryptococcus Neoformans
2
Product Code
JWL
Antigen, Treponema Pallidum For Fta-Abs Test
2
Product Code
JWT
Antigen, Cf, Aspergillus Spp.
1
Product Code
JWW
Antigen, Cf, B. Dermatitidis
2
Product Code
KFG
Antiserum, Positive Control, Aspergillus Spp.
1
Product Code
KFH
Antiserum, Positive Control, Blastomyces Dermatitidis
2
Product Code
KFI
Strip, Virulence, Corynebacterium Diphtheriae
1
Product Code
KHW
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
2
Product Code
KLH
Antisera, C. Acnes
1
Product Code
LFX
Enzyme Linked Immunoabsorbent Assay, Rubella
2
Product Code
LFY
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
2
Product Code
LFZ
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
2
Product Code
LGB
Gonococcal Antibody Tests
3
Product Code
LGC
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
2
Product Code
LGD
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
2
Product Code
LHJ
Staphylococcus Aureus Protein A Insoluble
1
Product Code
LHK
Antigen, Id, Candida Albicans
2
Product Code
LHL
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
2
Product Code
LHT
Staphylococcus Aureus Somatic Antigens
1
Product Code
LHW
Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
1
Product Code
LIA
Antigens, All Groups, Shigella Spp.
2
Product Code
LIC
Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
2
Product Code
LIN
Antisera, Conjugated Fluorescent, Cytomegalovirus
2
Product Code
LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
2
Product Code
LIQ
Enzyme Linked Immunoabsorbent Assay, Rotavirus
1
Product Code
LIR
Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
2
Product Code
LJB
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
1
Product Code
LJC
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
1
Product Code
LJK
Antisera, If, Toxoplasma Gondii
2
Product Code
LJN
Antibody Igm, If, Epstein-Barr Virus
1
Product Code
LJO
Antigen, Iha, Cytomegalovirus
2
Product Code
LJP
Antiserum, Fluorescent, Chlamydia Trachomatis
1
Product Code
LJY
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
1
Product Code
LJZ
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
1
Product Code
LKC
Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus
2
Product Code
LKH
Antisera, Immunoperoxidase, Chlamydia Spp.
1
Product Code
LKI
Antisera, Fluorescent, Chlamydia Spp.
1
Product Code
LKQ
Antibody Igm,If, Cytomegalovirus Virus
2
Product Code
LKT
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
1
Product Code
LLA
Direct Agglutination Test, Toxoplasma Gondii
2
Product Code
LLM
Test, Antigen, Nuclear, Epstein-Barr Virus
1
Product Code
LOL
Hepatitis A Test (Antibody And Igm Antibody)
2
Product Code
LOO
Reagent, Leishmanii Serological
1
Product Code
LQF
Dna-Reagents, Mycobacterium Spp.
1
Product Code
LQG
Dna-Reagents, Mycoplasma Spp.
1
Product Code
LQH
Dna-Reagents, Legionella
2
Product Code
LQN
Latex Agglutination Assay, Rubella
2
Product Code
LQO
Dna-Reagents, Campylobacter Spp.
1
Product Code
LQP
Campylobacter Spp.
1
Product Code
LRF
Candida Spp., Direct Antigen, Id
2
Product Code
LSD
Rubella, Other Assays
2
Product Code
LSE
Epstein-Barr Virus, Other
1
Product Code
LSF
Dna-Reagents, Epstein-Barr Virus
1
Product Code
LSG
Candida Species, Antibody Detection
2
Product Code
LSH
Antigen, Blastomyces Dermatitidis, Other
2
Product Code
LSI
Antiserum, Blastomyces Dermatitidis, Other
2
Product Code
LSJ
Antigen, Rubella, Other
2
Product Code
LSK
Dna-Reagents, Chlamydia
1
Product Code
LSL
Dna-Reagents, Neisseria
2
Product Code
LSM
Dna-Reagents, Salmonella Spp.
2
Product Code
LSN
Dna-Reagents, Shigella Spp.
2
Product Code
LSO
Dna-Reagents, Cytomegalovirus
2
Product Code
LSQ
Reagent, Rickettsia Serological
1
Product Code
LSR
Reagent, Borrelia Serological Reagent
2
Product Code
LYF
Pneumocystis Carinii
2
Product Code
LYR
Helicobacter Pylori
1
Product Code
MBT
Dna-Probe, Reagent, Histoplasma Capsulatum
2
Product Code
MCC
Dna-Probe, Haemophilus Spp.
2
Product Code
MCD
Antigen, Ebv, Capsid
1
Product Code
MCE
Respiratory Syncytial Virus - Elisa
1
Product Code
MCG
Dna-Probe, Agent, Listeria
1
Product Code
MCS
Dna-Probe, Staphylococcus Aureus
1
Product Code
MCT
Dna-Probe, Strep Pneumoniae
1
Product Code
MDC
Dna-Probe - Blastomyces Dermatitidis
2
Product Code
MDE
Dna-Probe, Reagents, Cryptococcal
2
Product Code
MDF
Dna-Probe, Reagents, Coccidioides Immitis
2
Product Code
MDJ
Reagents, Cysticercosis
1
Product Code
MDK
Dna-Probe, Reagents, Streptococcal
1
Product Code
MDT
Elisa, Trichinella Spiralis
1
Product Code
MDU
Antigen, Elisa, Cryptococcus
2
Product Code
MGM
C. Trachomatis (Chlamydia Group)
1
Product Code
MHI
Giardia Spp.
2
Product Code
MHJ
Cryptosporidium Spp.
2
Product Code
MIU
Enzyme Linked Immunosorbent Assay, T. Cruzi
1
Product Code
MIV
Immunofluorescent Assay, T. Cruzi
1
Product Code
MIY
Enzyme Linked Immunosorbent Assay, Coccidioides Immitis
2
Product Code
MIZ
Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
2
Product Code
MJH
Legionella, Spp., Elisa
2
Product Code
MJL
Eia, Blastomyces Dermatitidis
2
Product Code
MKZ
Dna Probe, Nucleic Acid Amplification, Chlamydia
1
Product Code
MSQ
Test, Urea (Breath Or Blood)
1
Product Code
MWA
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
2
Product Code
MXJ
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
2
Product Code
MYF
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
2
Product Code
NDZ
Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
1
Product Code
NGS
Assay, Endotoxin Activity, Chemiluminescent
2
Product Code
NHT
Assay, Nucleic Acid Amplification, Bacillus Anthracis
2
Product Code
NHY
Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus
1
Product Code
NHZ
Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus
1
Product Code
NIA
Assay, Direct, Nucleic Acid Amplification, Influenza Virus
1
Product Code
NJO
System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
1
Product Code
NJR
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
1
Product Code
NOM
Antigen, Galactomannan, Aspergillus Spp.
1
Product Code
NOP
Elisa, Antibody, West Nile Virus
2
Product Code
NPO
Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
2
Product Code
NQZ
Antigen, Invasive Fungal Pathogens
2
Product Code
NRL
Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
2
Product Code
NTM
Antigen, Inflammatory Response Marker, Sepsis
2
Product Code
NVQ
Bacteriophage And Controls, B. Anthracis Lysis
2
Product Code
NWZ
Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids
2
Product Code
NXD
Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
2
Product Code
NXX
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
1
Product Code
OAH
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
1
Product Code
OAI
Assay, Enterovirus Nucleic Acid
2
Product Code
OAX
Plasmodium Spp. Detection Reagents
2
Product Code
OMS
Novel Influenza A Virus, A/H5 Ns1 Protein
2
Product Code
OOU
Parainfluenza Multiplex Nucleic Acid Assay
2
Product Code
OCC
Respiratory Virus Panel Nucleic Acid Assay System
2
Product Code
OEH
Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
2
Product Code
OEM
Human Metapneumovirus (Hmpv) Rna Assay System
2
Product Code
OEP
Influenza A Virus Subtype Differentiation Nucleic Acid Assay
2
Product Code
OJY
Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers
2
Product Code
OMG
Antisera, Fluorescent, Human Metapneumovirus
2
Product Code
OMI
Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
2
Product Code
OPL
Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
2
Product Code
OPM
Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
2
Product Code
OQO
Herpes Simplex Virus Nucleic Acid Amplification Assay
2
Product Code
OQW
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
2
Product Code
OSU
Dengue Serological Reagents
2
Product Code
OTG
Non-Sars Coronavirus Multiplex Nucleic Acid Assay
2
Product Code
OUC
Norovirus Serological Reagent
2
Product Code
OUZ
Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
1
Product Code
OVF
Assay, Direct, Nucleic Acid Amplification, Q Fever
1
Product Code
OWF
Immunohistochemical Assay, Helicobacter Pylori
1
Product Code
OYP
Anti-Jcv Antibody Detection Assay
2
Product Code
OYZ
Group A Streptococcus Nucleic Acid Amplification Assay System
1
Product Code
OZA
Test, Urea Adult And Pediatric (Breath),
3
Product Code
OZB
Dengue Nucleic Acid Amplification Assay (Naat)
2
Product Code
OZE
Influenza A And Influenza B Multiplex Nucleic Acid Assay
2
Product Code
OZN
C. Difficile Toxin Gene Amplification Assay
2
Product Code
OZX
Mycoplasma Pneumoniae Dna Assay System
2
Product Code
OZY
Chlamydophila Pneumoniae Dna Assay System
2
Product Code
OZZ
Bordetella Pertussis Dna Assay System
2
Product Code
PAM
Gram-Positive Bacteria And Their Resistance Markers
2
Product Code
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
2
Product Code
PCI
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
2
Product Code
PCL
Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
1
Product Code
PEN
Gram-Negative Bacteria And Associated Resistance Markers
2
Product Code
PEO
Fungal Organisms, Nucleic Acid-Based Assay
2
Product Code
PEU
System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
2
Product Code
PEX
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
2
Product Code
PGI
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
2
Product Code
PII
Candida Species Nucleic Acid Detection System
2
Product Code
PIQ
Reagents For Detection Of Norovirus Nucleic Acid
2
Product Code
PIT
Leishmania Spp. Antigen Detection Assay
1
Product Code
PLO
Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
2
Product Code
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
2
Product Code
PMT
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
2
Product Code
QBH
Lower Respiratory Microbial Nucleic Acid Detection System
2
Product Code
PRE
Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
2
Product Code
PRI
Procalcitonin Assay
2
Product Code
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
2
Product Code
PTF
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
2
Product Code
PUQ
Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
2
Product Code
QBX
Direct Blood Bacterial Nucleic Acid Detection System
2
Product Code
QCH
Assayed Quality Control Material For Clinical Microbiology Assays
2
Product Code
QCU
Dengue Virus Antigen Assay
2
Product Code
QDP
Respiratory Panel
2
Product Code
QFS
Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
2
Product Code
QLX
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
2
Product Code
QMI
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
2
Product Code
QMV
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
2
Product Code
QOF
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
2
Product Code
K
24
2465
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
2
Cleared 510(K)
K
24
2353
QIAstat-Dx Respiratory Panel Mini
2
Cleared 510(K)
K
24
1240
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
2
Cleared 510(K)
K
24
1194
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
2
Cleared 510(K)
K
23
3100
QIAstat-Dx® Respiratory Panel Plus
2
Cleared 510(K)
K
23
2954
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
2
Cleared 510(K)
K
23
1758
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
2
Cleared 510(K)
K
23
3410
LIAISON PLEX Respiratory Flex Assay
2
Cleared 510(K)
K
23
1481
Xpert Xpress CoV-2/Flu/RSV plus
2
Cleared 510(K)
K
23
0956
BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System
2
Cleared 510(K)
K
22
3591
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
2
Cleared 510(K)
K
22
2736
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
2
Cleared 510(K)
K
23
0719
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
2
Cleared 510(K)
K
22
0963
Simplexa COVID-19 & Flu A/B Direct
2
Cleared 510(K)
K
21
3954
BIOFIRE SPOTFIRE Respiratory (R) Panel
2
Cleared 510(K)
DEN
20
0031
BioFire Respiratory Panel 2.1 (RP2.1)
2
Cleared 510(K)
QPS
Immunoassay For Host Biomarkers Of Infection
2
Product Code
QQX
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
2
Product Code
QST
Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test
2
Product Code
QSU
Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test
2
Product Code
QSV
Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test
2
Product Code
QTM
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.
2
Product Code
QUT
Deformability Cytometry For Sepsis Risk Assessment
2
Product Code
SCX
Immunoassay For Host Biomarkers Of Sepsis
2
Product Code
Subpart F—Immunological Test Systems
CFR Sub-Part
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
MI
/
subpart-d—serological-reagents
/
QOF
/
K222736
View Source
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222736
510(k) Type
Traditional
Applicant
Hologic, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/16/2023
Days to Decision
249 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Miscellaneous
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Serological Reagents
GOH
Antigens, Cf (Including Cf Control), Poliovirus 1-3
GOI
Antiserum, Fluorescent, Rabies Virus
GOJ
Antisera, Neutralization, Rubella
GOK
Antisera, Hai (Including Hai Control), Rubella
GOL
Antigen, Ha (Including Ha Control), Rubella
GOM
Antisera, Cf, Rubella
GON
Antigen, Cf (Including Cf Control), Rubella
GOO
Antisera, Fluorescent, All Globulins, Salmonella Spp.
GOP
Antisera, C. Acnes (553, 605)
GOS
Antiserum, Fluorescent, C. Diphtheriae
GOT
Antigen, B. Parapertussis
GOW
Antisera, Agglutinating, B. Parapertussis
GOX
Antigen, B. Pertussis
GOY
Antisera, Agglutinating, B. Pertussis, All
GOZ
Antisera, Fluorescent, B. Pertussis
OUY
Trichomonas Vaginalis Nucleic Acid Amplification Test System
GOD
Antigens, Cf (Including Cf Control), Adenovirus 1-33
GOE
Antisera, Fluorescent, Poliovirus 1-3
GOF
Antisera, Neutralization, Poliovirus 1-3
GOG
Antisera, Cf, Poliovirus 1-3
QIC
Hiv-1 Genotyping Assay Using Ngs Technology
GLZ
Antigens, If, Toxoplasma Gondii
GMA
Antisera, Fluorescent, Sporothrix Schenekii
GMD
Antisera, Latex Agglutination, Cryptococcus Neoformans
GME
Antisera, Fluorescent, Cryptococcus Neoformans
GMG
Antigen, Latex Agglutination, Coccidioides Immitis
GMH
Antiserum, Positive Control, Coccidioides Immitis
GMI
Antigen, Cf And / Or Id, Coccidioides Immitis
GMJ
Antigens, Histoplasma Capsulatum, All
GMK
Antiserum, Positive Control, Histoplasma Capsulatum
GML
Antisera, Fluorescent, Histoplasma Capsulatum
GMM
Antigens, Iha, Toxoplasma Gondii
GMN
Antigens, Cf, Toxoplasma Gondii
GMO
Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.
GMP
Antisera, Control For Nontreponemal Tests
GMQ
Antigens, Nontreponemal, All
GMR
Sera, Reactive And Non-Specific Control, Fta-Abs Test
GMS
Anti-Human Globulin, Fta-Abs Test
GMT
Antigens, Ha, Treponema Pallidum
GMW
Test, Sorbent, Fta-Abs
GMX
Antisera, Fluorescent Antibody For Fta-Abs Test
GMY
Antisera, Fluorescent, All Types, Escherichia Coli
GMZ
Antigens, All Types, Escherichia Coli
GNA
Antisera, All Types, Escherichia Coli
GNB
Antisera, All Types, Shigella Spp.
GNC
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
GND
Antigen, Iha, T. Cruzi
GNE
Antigen, Latex Agglutination, T. Cruzi
GNF
Antigen, Cf, T. Cruzi
GNG
Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6
GNH
Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
GNI
Antisera, Neutralization, Echovirus 1-34
GNJ
Antigens, Ha, Echovirus 1-34
GNK
Antisera, Cf, Echovirus 1-34
GNL
Antigens, Cf (Including Cf Control), Echovirus 1-34
GNM
Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
GNN
Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6
GNO
Antisera, Cf, Coxsackievirus A 1-24, B 1-6
GNP
Antiserum, Cf, Epstein-Barr Virus
GNQ
Antigen, Cf (Including Cf Control), Epstein-Barr Virus
GNR
Antisera, Neutralization, Influenza Virus A, B, C
GNS
Antisera, Hai, Influenza Virus A, B, C
GNT
Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
GNW
Antisera, Cf, Influenza Virus A, B, C
GNX
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
GNY
Antisera, Fluorescent, Adenovirus 1-33
GNZ
Antisera, Neutralization, Adenovirus 1-33
GOA
Antisera, Cf, Adenovirus 1-33
GOB
Antigens, Ha (Including Ha Control), Adenovirus 1-33
GOC
Antisera, Hai, Adenovirus 1-33
GPD
Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus
GPE
Antisera, Positive Control, Echinococcus Spp.
GPF
Antigen, Agglutinating, Echinococcus Spp.
GPG
Antigen, Latex Agglutination, Trichinella Spiralis
GPH
Antiserum, Bentonite Flocculation, Trichinella Spiralis
GPI
Antigen, Bentonite Flocculation, Trichinella Spiralis
GPJ
Antiserum, Fluorescent, Q Fever
GPK
Antiserum, Rickettsial Pox
GPM
Antiserum, Murine Typhus Fever
GPN
Antiserum, Typhus Fever
GPO
Antigen, Cf, Typhus Fever Group
GPP
Antiserum, Rocky Mountain Spotted Fever
GPQ
Antigen, Cf, Spotted Fever Group
GPR
Antiserum, Cf, Q Fever
GPS
Antigen, Cf, Q Fever
GPT
Antiserum, Cf, Psittacosis (Chlamydia Group)
GPW
Antigen, Cf, Psittacosis (Chlamydia Group)
GPX
Antisera, Neutralizion, Reovirus 1-3
GPY
Antisera, Hai, Reovirus 1-3
GPZ
Antisera, Cf, Reovirus 1-3
GQA
Antigens, Ha (Including Ha Control), Reovirus 1-3
GQB
Antigens, Cf (Including Cf Control), Reovirus 1-3
GQC
Antisera, Cf, Equine Encephalitis Virus, Eee, Wee
GQD
Antigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee
GQE
Antisera, Neutralization, All Types, Rhinovirus
GQF
Antiserum, Neutralization, Respiratory Syncytial Virus
GQG
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
GQH
Antigen, Cf (Including Cf Control), Cytomegalovirus
GQI
Antiserum, Cf, Cytomegalovirus
GQJ
Antiserum, Cf, Lymphocytic Choriomeningitis Virus
GQK
Antigen, Cf, Lymphocytic Choriomeningitis Virus
GQL
Antisera, Fluorescent, Herpesvirus Hominis 1,2
GQM
Antisera, Neutralization, Herpesvirus Hominis
GQN
Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
GQO
Antisera, Cf, Herpesvirus Hominis 1,2
GQP
Antisera, Neutralization, Parainfluenza Virus 1-4
GQQ
Antisera, Hai, Parainfluenza Virus 1-4
GQR
Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4
GQS
Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
GQT
Antisera, Cf, Parainfluenza Virus 1-4
GQW
Antigen, Cf, (Including Cf Control), Varicella-Zoster
GQX
Antiserum, Cf, Varicella-Zoster
GQY
Antigen, Ha (Including Ha Control), Mumps Virus
GQZ
Antiserum, Neutralization, Mumps Virus
GRA
Antiserum, Fluorescent, Mumps Virus
GRB
Antiserum, Cf, Mumps Virus
GRC
Antigen, Cf (Including Cf Control), Mumps Virus
GRD
Antiserum, Hai, Mumps Virus
GRE
Antiserum, Fluorescent, Rubeola
GRF
Antiserum, Cf, Rubeola
GRG
Antiserum, Hai, Rubeola
GRH
Antigen, Ha (Including Ha Control), Rubeola
GRI
Antiserum, Neutralization, Rubeola
GRJ
Antigen, Cf, (Including Cf Control), Rubeola
GRK
Antisera, Fluorescent, Echovirus 1-34
GRL
Antigens, All Groups, Salmonella Spp.
GRM
Antisera, All Groups, Salmonella Spp.
GRO
Antisera, Fluorescent, All Types, Hemophilus Spp.
GRP
Antisera, All Types, H. Influenza
GRT
Antiserum, Fluorescent, Mycobacterium Tuberculosis
GRW
Antisera, All Fluorescent, Leptospira Spp.
GRX
Antisera, All Leptospira Spp.
GRY
Antigens, All, Leptospira Spp.
GRZ
Antisera, Fluorescent, All, Mycoplasma Spp.
GSA
Antisera, All Mycoplasma Spp.
GSB
Antigens, Cf, All, Mycoplasma Spp.
GSD
Antiserum, Fluorescent, Erysipelothrix Rhusiopathiae
GSE
Antiserum, Erysipelothrix Rhusiopathiae
GSF
Antigen, Erysipelothrix Rhusiopathiae
GSG
Antisera, Fluorescent, All Types, Listeria Monocytogenes
GSH
Antisera, All Types, Listeria Monocytogenes
GSI
Antigens, Slide And Tube, All Types, Listeria Monocytogenes
GSJ
Antiserum, Fluorescent, Francisella Tularensis
GSK
Antiserum, Francisella Tularensis
GSL
Antigens, Slide And Tube, Francisella Tularensis
GSM
Antisera, Fluorescent, Brucella Spp.
GSN
Antiserum, Positive And Negative Febrile Antigen Control Serum
GSO
Antigens (Febrile), Agglutination, Brucella Spp.
GSP
Antiserum, Fluorescent, Campylobacter Fetus
GSQ
Antiserum, Vibrio Cholerae, All Varieties
GSR
Antisera, Fluorescent, Pseudomonas Pseudomallei
GSS
Antisera, Fluorescent, Pseudomonas Aeruginosa
GST
Antiserum, Pseudomonas Pseudomallei
GSW
Antiserum, Flavobacterium Meningosepticum, All Groups
GSX
Antisera, Acinetobacter Calcoaceticus, All Varieties
GSY
Antisera, Fluorescent, All Globulins, Proteus Spp.
GSZ
Antigens, Febrile (Weil-Felix), All Groups
GTA
Antisera, All, Serratia Marcesans
GTB
Antisera, Fluorescent, All Types, Klebsiella Spp.
GTC
Antisera, All Types, Klebsiella Spp.
GTD
Antisera, Fluorescent, All Globulins, Shigella Spp.
GTE
Antisera, Arizona Spp., All
GTF
Antisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.
GTH
Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
GTI
Antisera, Fluorescent, All Groups, N. Meningitidis
GTJ
Antisera, All Groups, N. Meningitidis
GTN
Antisera, Fluorescent, All Types, Staphylococcus Spp.
GTO
Anti-Streptokinase
GTP
Exoenzymes, Multiple, Streptococcal
GTQ
Antistreptolysin - Titer/Streptolysin O Reagent
GTR
Antideoxyribonuclease, Streptococcus Spp.
GTX
Antisera, Fluorescent, All Groups, Streptococcus Spp.
GTY
Antigens, All Groups, Streptococcus Spp.
GTZ
Antisera, All Groups, Streptococcus Spp.
GWB
Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
GWC
Antisera, All Types, Streptococcus Pneumoniae
GWD
Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
JRW
Antisera, Fluorescent, B. Parapertussis
JRY
Antiserum, Fluorescent, Epstein-Barr Virus
JWK
Antigen, Positive Control, Cryptococcus Neoformans
JWL
Antigen, Treponema Pallidum For Fta-Abs Test
JWT
Antigen, Cf, Aspergillus Spp.
JWW
Antigen, Cf, B. Dermatitidis
KFG
Antiserum, Positive Control, Aspergillus Spp.
KFH
Antiserum, Positive Control, Blastomyces Dermatitidis
KFI
Strip, Virulence, Corynebacterium Diphtheriae
KHW
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
KLH
Antisera, C. Acnes
LFX
Enzyme Linked Immunoabsorbent Assay, Rubella
LFY
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
LFZ
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
LGB
Gonococcal Antibody Tests
LGC
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
LGD
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
LHJ
Staphylococcus Aureus Protein A Insoluble
LHK
Antigen, Id, Candida Albicans
LHL
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
LHT
Staphylococcus Aureus Somatic Antigens
LHW
Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
LIA
Antigens, All Groups, Shigella Spp.
LIC
Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
LIN
Antisera, Conjugated Fluorescent, Cytomegalovirus
LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
LIQ
Enzyme Linked Immunoabsorbent Assay, Rotavirus
LIR
Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
LJB
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
LJC
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
LJK
Antisera, If, Toxoplasma Gondii
LJN
Antibody Igm, If, Epstein-Barr Virus
LJO
Antigen, Iha, Cytomegalovirus
LJP
Antiserum, Fluorescent, Chlamydia Trachomatis
LJY
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
LJZ
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
LKC
Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus
LKH
Antisera, Immunoperoxidase, Chlamydia Spp.
LKI
Antisera, Fluorescent, Chlamydia Spp.
LKQ
Antibody Igm,If, Cytomegalovirus Virus
LKT
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
LLA
Direct Agglutination Test, Toxoplasma Gondii
LLM
Test, Antigen, Nuclear, Epstein-Barr Virus
LOL
Hepatitis A Test (Antibody And Igm Antibody)
LOO
Reagent, Leishmanii Serological
LQF
Dna-Reagents, Mycobacterium Spp.
LQG
Dna-Reagents, Mycoplasma Spp.
LQH
Dna-Reagents, Legionella
LQN
Latex Agglutination Assay, Rubella
LQO
Dna-Reagents, Campylobacter Spp.
LQP
Campylobacter Spp.
LRF
Candida Spp., Direct Antigen, Id
LSD
Rubella, Other Assays
LSE
Epstein-Barr Virus, Other
LSF
Dna-Reagents, Epstein-Barr Virus
LSG
Candida Species, Antibody Detection
LSH
Antigen, Blastomyces Dermatitidis, Other
LSI
Antiserum, Blastomyces Dermatitidis, Other
LSJ
Antigen, Rubella, Other
LSK
Dna-Reagents, Chlamydia
LSL
Dna-Reagents, Neisseria
LSM
Dna-Reagents, Salmonella Spp.
LSN
Dna-Reagents, Shigella Spp.
LSO
Dna-Reagents, Cytomegalovirus
LSQ
Reagent, Rickettsia Serological
LSR
Reagent, Borrelia Serological Reagent
LYF
Pneumocystis Carinii
LYR
Helicobacter Pylori
MBT
Dna-Probe, Reagent, Histoplasma Capsulatum
MCC
Dna-Probe, Haemophilus Spp.
MCD
Antigen, Ebv, Capsid
MCE
Respiratory Syncytial Virus - Elisa
MCG
Dna-Probe, Agent, Listeria
MCS
Dna-Probe, Staphylococcus Aureus
MCT
Dna-Probe, Strep Pneumoniae
MDC
Dna-Probe - Blastomyces Dermatitidis
MDE
Dna-Probe, Reagents, Cryptococcal
MDF
Dna-Probe, Reagents, Coccidioides Immitis
MDJ
Reagents, Cysticercosis
MDK
Dna-Probe, Reagents, Streptococcal
MDT
Elisa, Trichinella Spiralis
MDU
Antigen, Elisa, Cryptococcus
MGM
C. Trachomatis (Chlamydia Group)
MHI
Giardia Spp.
MHJ
Cryptosporidium Spp.
MIU
Enzyme Linked Immunosorbent Assay, T. Cruzi
MIV
Immunofluorescent Assay, T. Cruzi
MIY
Enzyme Linked Immunosorbent Assay, Coccidioides Immitis
MIZ
Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
MJH
Legionella, Spp., Elisa
MJL
Eia, Blastomyces Dermatitidis
MKZ
Dna Probe, Nucleic Acid Amplification, Chlamydia
MSQ
Test, Urea (Breath Or Blood)
MWA
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
MXJ
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
MYF
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
NDZ
Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
NGS
Assay, Endotoxin Activity, Chemiluminescent
NHT
Assay, Nucleic Acid Amplification, Bacillus Anthracis
NHY
Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus
NHZ
Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus
NIA
Assay, Direct, Nucleic Acid Amplification, Influenza Virus
NJO
System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
NJR
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
NOM
Antigen, Galactomannan, Aspergillus Spp.
NOP
Elisa, Antibody, West Nile Virus
NPO
Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
NQZ
Antigen, Invasive Fungal Pathogens
NRL
Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
NTM
Antigen, Inflammatory Response Marker, Sepsis
NVQ
Bacteriophage And Controls, B. Anthracis Lysis
NWZ
Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids
NXD
Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
NXX
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
OAH
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
OAI
Assay, Enterovirus Nucleic Acid
OAX
Plasmodium Spp. Detection Reagents
OMS
Novel Influenza A Virus, A/H5 Ns1 Protein
OOU
Parainfluenza Multiplex Nucleic Acid Assay
OCC
Respiratory Virus Panel Nucleic Acid Assay System
OEH
Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
OEM
Human Metapneumovirus (Hmpv) Rna Assay System
OEP
Influenza A Virus Subtype Differentiation Nucleic Acid Assay
OJY
Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers
OMG
Antisera, Fluorescent, Human Metapneumovirus
OMI
Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
OPL
Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
OPM
Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
OQO
Herpes Simplex Virus Nucleic Acid Amplification Assay
OQW
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
OSU
Dengue Serological Reagents
OTG
Non-Sars Coronavirus Multiplex Nucleic Acid Assay
OUC
Norovirus Serological Reagent
OUZ
Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
OVF
Assay, Direct, Nucleic Acid Amplification, Q Fever
OWF
Immunohistochemical Assay, Helicobacter Pylori
OYP
Anti-Jcv Antibody Detection Assay
OYZ
Group A Streptococcus Nucleic Acid Amplification Assay System
OZA
Test, Urea Adult And Pediatric (Breath),
OZB
Dengue Nucleic Acid Amplification Assay (Naat)
OZE
Influenza A And Influenza B Multiplex Nucleic Acid Assay
OZN
C. Difficile Toxin Gene Amplification Assay
OZX
Mycoplasma Pneumoniae Dna Assay System
OZY
Chlamydophila Pneumoniae Dna Assay System
OZZ
Bordetella Pertussis Dna Assay System
PAM
Gram-Positive Bacteria And Their Resistance Markers
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
PCI
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
PCL
Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
PEN
Gram-Negative Bacteria And Associated Resistance Markers
PEO
Fungal Organisms, Nucleic Acid-Based Assay
PEU
System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
PEX
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
PGI
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
PII
Candida Species Nucleic Acid Detection System
PIQ
Reagents For Detection Of Norovirus Nucleic Acid
PIT
Leishmania Spp. Antigen Detection Assay
PLO
Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
PMT
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
QBH
Lower Respiratory Microbial Nucleic Acid Detection System
PRE
Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
PRI
Procalcitonin Assay
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
PTF
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
PUQ
Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
QBX
Direct Blood Bacterial Nucleic Acid Detection System
QCH
Assayed Quality Control Material For Clinical Microbiology Assays
QCU
Dengue Virus Antigen Assay
QDP
Respiratory Panel
QFS
Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
QLX
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
QMI
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
QMV
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
QOF
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
K
24
2465
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
K
24
2353
QIAstat-Dx Respiratory Panel Mini
K
24
1240
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K
24
1194
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
K
23
3100
QIAstat-Dx® Respiratory Panel Plus
K
23
2954
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
K
23
1758
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
K
23
3410
LIAISON PLEX Respiratory Flex Assay
K
23
1481
Xpert Xpress CoV-2/Flu/RSV plus
K
23
0956
BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System
K
22
3591
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
K
22
2736
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K
23
0719
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
K
22
0963
Simplexa COVID-19 & Flu A/B Direct
K
21
3954
BIOFIRE SPOTFIRE Respiratory (R) Panel
DEN
20
0031
BioFire Respiratory Panel 2.1 (RP2.1)
QPS
Immunoassay For Host Biomarkers Of Infection
QQX
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
QST
Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test
QSU
Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test
QSV
Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test
QTM
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.
QUT
Deformability Cytometry For Sepsis Risk Assessment
SCX
Immunoassay For Host Biomarkers Of Sepsis
Subpart F—Immunological Test Systems
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
MI
/
subpart-d—serological-reagents
/
QOF
/
K222736
View Source
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222736
510(k) Type
Traditional
Applicant
Hologic, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/16/2023
Days to Decision
249 days
Submission Type
Summary