Part 866 Subpart D—Serological Reagents
FDA submissions for Part 866 Subpart D—Serological Reagents in the Microbiology (MI) review panel, including product codes and regulations.
Section range: §§ 866.3010–866.3990
CFR Part: 866
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| GSX | Antisera, Acinetobacter Calcoaceticus, All Varieties | 866.3010 | 1 | 0 |
| GNY | Antisera, Fluorescent, Adenovirus 1-33 | 866.3020 | 1 | 4 |
| GNZ | Antisera, Neutralization, Adenovirus 1-33 | 866.3020 | 1 | 0 |
| GOA | Antisera, Cf, Adenovirus 1-33 | 866.3020 | 1 | 1 |
| GOB | Antigens, Ha (Including Ha Control), Adenovirus 1-33 | 866.3020 | 1 | 1 |
| GOC | Antisera, Hai, Adenovirus 1-33 | 866.3020 | 1 | 0 |
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 866.3020 | 1 | 11 |
| GTE | Antisera, Arizona Spp., All | 866.3035 | 1 | 0 |
| JWT | Antigen, Cf, Aspergillus Spp. | 866.3040 | 1 | 5 |
| KFG | Antiserum, Positive Control, Aspergillus Spp. | 866.3040 | 1 | 5 |
| NOM | Antigen, Galactomannan, Aspergillus Spp. | 866.3040 | 1 | 4 |
| NHT | Assay, Nucleic Acid Amplification, Bacillus Anthracis | 866.3045 | 2 | 6 |
| NPO | Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody | 866.3045 | 2 | 1 |
| NRL | Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis | 866.3045 | 2 | 1 |
| NVQ | Bacteriophage And Controls, B. Anthracis Lysis | 866.3045 | 2 | 2 |
| NWZ | Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids | 866.3045 | 2 | 1 |
| QUU | Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples | 866.3046 | 2 | 2 |
| NQZ | Antigen, Invasive Fungal Pathogens | 866.3050 | 2 | 2 |
| JWW | Antigen, Cf, B. Dermatitidis | 866.3060 | 2 | 3 |
| KFH | Antiserum, Positive Control, Blastomyces Dermatitidis | 866.3060 | 2 | 4 |
| LSH | Antigen, Blastomyces Dermatitidis, Other | 866.3060 | 2 | 0 |
| LSI | Antiserum, Blastomyces Dermatitidis, Other | 866.3060 | 2 | 0 |
| MDC | Dna-Probe - Blastomyces Dermatitidis | 866.3060 | 2 | 1 |
| MJL | Eia, Blastomyces Dermatitidis | 866.3060 | 2 | 2 |
| GOT | Antigen, B. Parapertussis | 866.3065 | 1 | 0 |
| GOW | Antisera, Agglutinating, B. Parapertussis | 866.3065 | 1 | 0 |
| GOX | Antigen, B. Pertussis | 866.3065 | 1 | 1 |
| GOY | Antisera, Agglutinating, B. Pertussis, All | 866.3065 | 1 | 1 |
| GOZ | Antisera, Fluorescent, B. Pertussis | 866.3065 | 1 | 0 |
| JRW | Antisera, Fluorescent, B. Parapertussis | 866.3065 | 1 | 2 |
| GSM | Antisera, Fluorescent, Brucella Spp. | 866.3085 | 2 | 4 |
| GSN | Antiserum, Positive And Negative Febrile Antigen Control Serum | 866.3085 | 2 | 3 |
| GSO | Antigens (Febrile), Agglutination, Brucella Spp. | 866.3085 | 2 | 12 |
| GSP | Antiserum, Fluorescent, Campylobacter Fetus | 866.3110 | 1 | 0 |
| LQO | Dna-Reagents, Campylobacter Spp. | 866.3110 | 1 | 4 |
| LQP | Campylobacter Spp. | 866.3110 | 1 | 12 |
| LYR | Helicobacter Pylori | 866.3110 | 1 | 91 |
| MSQ | Test, Urea (Breath Or Blood) | 866.3110 | 1 | 17 |
| OWF | Immunohistochemical Assay, Helicobacter Pylori | 866.3110 | 1 | 1 |
| OZA | Test, Urea Adult And Pediatric (Breath), | 866.3110 | 3 | 2 |
| GPT | Antiserum, Cf, Psittacosis (Chlamydia Group) | 866.3120 | 1 | 1 |
| GPW | Antigen, Cf, Psittacosis (Chlamydia Group) | 866.3120 | 1 | 4 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 866.3120 | 1 | 67 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 866.3120 | 1 | 35 |
| LKH | Antisera, Immunoperoxidase, Chlamydia Spp. | 866.3120 | 1 | 8 |
| LKI | Antisera, Fluorescent, Chlamydia Spp. | 866.3120 | 1 | 6 |
| LSK | Dna-Reagents, Chlamydia | 866.3120 | 1 | 8 |
| MGM | C. Trachomatis (Chlamydia Group) | 866.3120 | 1 | 0 |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | 866.3120 | 1 | 19 |
| GTF | Antisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp. | 866.3125 | 1 | 0 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 866.3130 | 2 | 17 |
| GMG | Antigen, Latex Agglutination, Coccidioides Immitis | 866.3135 | 2 | 5 |
| GMH | Antiserum, Positive Control, Coccidioides Immitis | 866.3135 | 2 | 5 |
| GMI | Antigen, Cf And / Or Id, Coccidioides Immitis | 866.3135 | 2 | 11 |
| MDF | Dna-Probe, Reagents, Coccidioides Immitis | 866.3135 | 2 | 1 |
| MIY | Enzyme Linked Immunosorbent Assay, Coccidioides Immitis | 866.3135 | 2 | 1 |
| GOP | Antisera, C. Acnes (553, 605) | 866.3140 | 1 | 0 |
| GOS | Antiserum, Fluorescent, C. Diphtheriae | 866.3140 | 1 | 0 |
| KFI | Strip, Virulence, Corynebacterium Diphtheriae | 866.3140 | 1 | 0 |
| KLH | Antisera, C. Acnes | 866.3140 | 1 | 1 |
| GNG | Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6 | 866.3145 | 1 | 2 |
| GNM | Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 | 866.3145 | 1 | 9 |
| GNN | Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6 | 866.3145 | 1 | 1 |
| GNO | Antisera, Cf, Coxsackievirus A 1-24, B 1-6 | 866.3145 | 1 | 1 |
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | 866.3165 | 2 | 10 |
| GME | Antisera, Fluorescent, Cryptococcus Neoformans | 866.3165 | 2 | 0 |
| JWK | Antigen, Positive Control, Cryptococcus Neoformans | 866.3165 | 2 | 1 |
| LHK | Antigen, Id, Candida Albicans | 866.3165 | 2 | 4 |
| LRF | Candida Spp., Direct Antigen, Id | 866.3165 | 2 | 3 |
| LSG | Candida Species, Antibody Detection | 866.3165 | 2 | 0 |
| MDE | Dna-Probe, Reagents, Cryptococcal | 866.3165 | 2 | 1 |
| MDU | Antigen, Elisa, Cryptococcus | 866.3165 | 2 | 2 |
| MZO | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | 866.3169 | 2 | 11 |
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | 866.3170 | 2 | 13 |
| OBF | Assay, Genotyping, Hepatitis C Virus | 866.3170 | 2 | 2 |
| SBP | Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test | 866.3171 | 2 | 1 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 866.3172 | 2 | 25 |
| SEI | Qualitative And Quantitative Hepatitis B Virus Antibody Assays | 866.3173 | 2 | 34 |
| MKT | Hepatitis Viral B Dna Detection | 866.3174 | 2 | 5 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 866.3175 | 2 | 19 |
| GQI | Antiserum, Cf, Cytomegalovirus | 866.3175 | 2 | 18 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 866.3175 | 2 | 58 |
| LIN | Antisera, Conjugated Fluorescent, Cytomegalovirus | 866.3175 | 2 | 17 |
| LJO | Antigen, Iha, Cytomegalovirus | 866.3175 | 2 | 12 |
| LKQ | Antibody Igm,If, Cytomegalovirus Virus | 866.3175 | 2 | 18 |
| LSO | Dna-Reagents, Cytomegalovirus | 866.3175 | 2 | 0 |
| PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | 866.3180 | 2 | 9 |
| QDZ | Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection | 866.3181 | 2 | 2 |
| QLX | Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna | 866.3183 | 2 | 4 |
| QMI | Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna | 866.3183 | 2 | 2 |
| GPD | Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus | 866.3200 | 1 | 0 |
| GPE | Antisera, Positive Control, Echinococcus Spp. | 866.3200 | 1 | 0 |
| GPF | Antigen, Agglutinating, Echinococcus Spp. | 866.3200 | 1 | 1 |
| MDJ | Reagents, Cysticercosis | 866.3200 | 1 | 1 |
| GNI | Antisera, Neutralization, Echovirus 1-34 | 866.3205 | 1 | 0 |
| GNJ | Antigens, Ha, Echovirus 1-34 | 866.3205 | 1 | 1 |
| GNK | Antisera, Cf, Echovirus 1-34 | 866.3205 | 1 | 3 |
| GNL | Antigens, Cf (Including Cf Control), Echovirus 1-34 | 866.3205 | 1 | 2 |
| GRK | Antisera, Fluorescent, Echovirus 1-34 | 866.3205 | 1 | 0 |
| NGS | Assay, Endotoxin Activity, Chemiluminescent | 866.3210 | 2 | 2 |
| NTM | Antigen, Inflammatory Response Marker, Sepsis | 866.3210 | 2 | 3 |
| PMT | Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | 866.3215 | 2 | 5 |
| PRE | Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers | 866.3215 | 2 | 4 |
| PRI | Procalcitonin Assay | 866.3215 | 2 | 8 |
| PTF | Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission | 866.3215 | 2 | 4 |
| QFS | Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment | 866.3215 | 2 | 1 |
| QPS | Immunoassay For Host Biomarkers Of Infection | 866.3215 | 2 | 4 |
| QUT | Deformability Cytometry For Sepsis Risk Assessment | 866.3215 | 2 | 3 |
| SCX | Immunoassay For Host Biomarkers Of Sepsis | 866.3215 | 2 | 1 |
| GMO | Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. | 866.3220 | 2 | 0 |
| GWD | Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp | 866.3220 | 2 | 2 |
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | 866.3220 | 2 | 18 |
| MHI | Giardia Spp. | 866.3220 | 2 | 27 |
| MHJ | Cryptosporidium Spp. | 866.3220 | 2 | 15 |
| OAI | Assay, Enterovirus Nucleic Acid | 866.3225 | 2 | 2 |
| QGN | Lateral Flow Immunochromatography Assay For Host Infection Biomarkers | 866.3230 | 2 | 2 |
| QXA | Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection | 866.3230 | 2 | 2 |
| QFA | Assay For Detection Of Proteases In Chronic Wounds | 866.3231 | 2 | 1 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 866.3235 | 1 | 20 |
| GNQ | Antigen, Cf (Including Cf Control), Epstein-Barr Virus | 866.3235 | 1 | 0 |
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | 866.3235 | 1 | 9 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 866.3235 | 1 | 23 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 866.3235 | 1 | 27 |
| LSE | Epstein-Barr Virus, Other | 866.3235 | 1 | 56 |
| LSF | Dna-Reagents, Epstein-Barr Virus | 866.3235 | 1 | 0 |
| MCD | Antigen, Ebv, Capsid | 866.3235 | 1 | 8 |
| OJY | Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers | 866.3236 | 2 | 1 |
| GQC | Antisera, Cf, Equine Encephalitis Virus, Eee, Wee | 866.3240 | 1 | 2 |
| GQD | Antigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee | 866.3240 | 1 | 0 |
| GSD | Antiserum, Fluorescent, Erysipelothrix Rhusiopathiae | 866.3250 | 1 | 0 |
| GSE | Antiserum, Erysipelothrix Rhusiopathiae | 866.3250 | 1 | 0 |
| GSF | Antigen, Erysipelothrix Rhusiopathiae | 866.3250 | 1 | 0 |
| GMY | Antisera, Fluorescent, All Types, Escherichia Coli | 866.3255 | 1 | 2 |
| GMZ | Antigens, All Types, Escherichia Coli | 866.3255 | 1 | 14 |
| GNA | Antisera, All Types, Escherichia Coli | 866.3255 | 1 | 12 |
| GSW | Antiserum, Flavobacterium Meningosepticum, All Groups | 866.3270 | 1 | 0 |
| GSJ | Antiserum, Fluorescent, Francisella Tularensis | 866.3280 | 2 | 1 |
| GSK | Antiserum, Francisella Tularensis | 866.3280 | 2 | 1 |
| GSL | Antigens, Slide And Tube, Francisella Tularensis | 866.3280 | 2 | 1 |
| OEH | Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit | 866.3280 | 2 | 2 |
| LGB | Gonococcal Antibody Tests | 866.3290 | 3 | 1 |
| GRO | Antisera, Fluorescent, All Types, Hemophilus Spp. | 866.3300 | 2 | 4 |
| GRP | Antisera, All Types, H. Influenza | 866.3300 | 2 | 6 |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 866.3300 | 2 | 18 |
| LQH | Dna-Reagents, Legionella | 866.3300 | 2 | 2 |
| MCC | Dna-Probe, Haemophilus Spp. | 866.3300 | 2 | 2 |
| MJH | Legionella, Spp., Elisa | 866.3300 | 2 | 10 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 866.3305 | 2 | 37 |
| GQM | Antisera, Neutralization, Herpesvirus Hominis | 866.3305 | 2 | 3 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 866.3305 | 2 | 34 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 866.3305 | 2 | 16 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 866.3305 | 2 | 38 |
| LKC | Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus | 866.3305 | 2 | 0 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 866.3305 | 2 | 20 |
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 866.3305 | 2 | 10 |
| OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 866.3305 | 2 | 12 |
| PGH | Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel | 866.3307 | 2 | 3 |
| PGI | Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | 866.3309 | 2 | 9 |
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | 866.3310 | 2 | 33 |
| PBK | Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set | 866.3315 | 2 | 5 |
| PRA | Variola Virus Nucleic Acid-Based Detection Assay | 866.3316 | 2 | 1 |
| PVQ | Rickettsia Spp. Nucleic Acid Based Detection Assay | 866.3316 | 2 | 1 |
| GMJ | Antigens, Histoplasma Capsulatum, All | 866.3320 | 2 | 12 |
| GMK | Antiserum, Positive Control, Histoplasma Capsulatum | 866.3320 | 2 | 9 |
| GML | Antisera, Fluorescent, Histoplasma Capsulatum | 866.3320 | 2 | 0 |
| MBT | Dna-Probe, Reagent, Histoplasma Capsulatum | 866.3320 | 2 | 1 |
| MIZ | Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum | 866.3320 | 2 | 2 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 866.3328 | 2 | 72 |
| GNR | Antisera, Neutralization, Influenza Virus A, B, C | 866.3330 | 1 | 1 |
| GNS | Antisera, Hai, Influenza Virus A, B, C | 866.3330 | 1 | 9 |
| GNT | Antigens, Ha (Including Ha Control), Influenza Virus A, B, C | 866.3330 | 1 | 5 |
| GNW | Antisera, Cf, Influenza Virus A, B, C | 866.3330 | 1 | 16 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 866.3330 | 1 | 18 |
| NIA | Assay, Direct, Nucleic Acid Amplification, Influenza Virus | 866.3330 | 1 | 0 |
| NXD | Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna | 866.3332 | 2 | 3 |
| OMS | Novel Influenza A Virus, A/H5 Ns1 Protein | 866.3332 | 2 | 1 |
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 866.3332 | 2 | 10 |
| OYP | Anti-Jcv Antibody Detection Assay | 866.3336 | 2 | 2 |
| GTB | Antisera, Fluorescent, All Types, Klebsiella Spp. | 866.3340 | 1 | 0 |
| GTC | Antisera, All Types, Klebsiella Spp. | 866.3340 | 1 | 1 |
| GRW | Antisera, All Fluorescent, Leptospira Spp. | 866.3350 | 2 | 0 |
| GRX | Antisera, All Leptospira Spp. | 866.3350 | 2 | 0 |
| GRY | Antigens, All, Leptospira Spp. | 866.3350 | 2 | 2 |
| GSG | Antisera, Fluorescent, All Types, Listeria Monocytogenes | 866.3355 | 1 | 0 |
| GSH | Antisera, All Types, Listeria Monocytogenes | 866.3355 | 1 | 1 |
| GSI | Antigens, Slide And Tube, All Types, Listeria Monocytogenes | 866.3355 | 1 | 1 |
| MCG | Dna-Probe, Agent, Listeria | 866.3355 | 1 | 0 |
| GQJ | Antiserum, Cf, Lymphocytic Choriomeningitis Virus | 866.3360 | 1 | 0 |
| GQK | Antigen, Cf, Lymphocytic Choriomeningitis Virus | 866.3360 | 1 | 0 |
| PEX | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | 866.3361 | 2 | 5 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 866.3365 | 2 | 6 |
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | 866.3365 | 2 | 11 |
| PEO | Fungal Organisms, Nucleic Acid-Based Assay | 866.3365 | 2 | 2 |
| PYN | Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. | 866.3367 | 2 | 1 |
| GRT | Antiserum, Fluorescent, Mycobacterium Tuberculosis | 866.3370 | 1 | 1 |
| LQF | Dna-Reagents, Mycobacterium Spp. | 866.3370 | 1 | 15 |
| NDZ | Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis | 866.3370 | 1 | 1 |
| NJO | System, Mycolic Acid Analysis, Mycobacterium Tuberculosis | 866.3370 | 1 | 1 |
| MWA | System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex | 866.3372 | 2 | 2 |
| PEU | System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen | 866.3373 | 2 | 2 |
| GRZ | Antisera, Fluorescent, All, Mycoplasma Spp. | 866.3375 | 1 | 5 |
| GSA | Antisera, All Mycoplasma Spp. | 866.3375 | 1 | 6 |
| GSB | Antigens, Cf, All, Mycoplasma Spp. | 866.3375 | 1 | 5 |
| LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | 866.3375 | 1 | 13 |
| LQG | Dna-Reagents, Mycoplasma Spp. | 866.3375 | 1 | 1 |
| QAA | Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens | 866.3376 | 2 | 1 |
| QBN | Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | 866.3378 | 2 | 4 |
| QNJ | Mass Spectrometry, Microorganism Identification, Blood Culture | 866.3378 | 2 | 2 |
| QQV | Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry | 866.3378 | 2 | 4 |
| GQY | Antigen, Ha (Including Ha Control), Mumps Virus | 866.3380 | 1 | 0 |
| GQZ | Antiserum, Neutralization, Mumps Virus | 866.3380 | 1 | 0 |
| GRA | Antiserum, Fluorescent, Mumps Virus | 866.3380 | 1 | 3 |
| GRB | Antiserum, Cf, Mumps Virus | 866.3380 | 1 | 2 |
| GRC | Antigen, Cf (Including Cf Control), Mumps Virus | 866.3380 | 1 | 3 |
| GRD | Antiserum, Hai, Mumps Virus | 866.3380 | 1 | 1 |
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 866.3380 | 1 | 8 |
| QYA | System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home | 866.3385 | 2 | 2 |
| SEA | Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users | 866.3386 | 2 | 1 |
| GTH | Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae | 866.3390 | 2 | 3 |
| GTI | Antisera, Fluorescent, All Groups, N. Meningitidis | 866.3390 | 2 | 2 |
| GTJ | Antisera, All Groups, N. Meningitidis | 866.3390 | 2 | 16 |
| LIC | Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae | 866.3390 | 2 | 9 |
| LIR | Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae | 866.3390 | 2 | 3 |
| LSL | Dna-Reagents, Neisseria | 866.3390 | 2 | 45 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 866.3393 | 2 | 21 |
| OUC | Norovirus Serological Reagent | 866.3395 | 2 | 1 |
| GQP | Antisera, Neutralization, Parainfluenza Virus 1-4 | 866.3400 | 1 | 2 |
| GQQ | Antisera, Hai, Parainfluenza Virus 1-4 | 866.3400 | 1 | 1 |
| GQR | Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4 | 866.3400 | 1 | 1 |
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 866.3400 | 1 | 11 |
| GQT | Antisera, Cf, Parainfluenza Virus 1-4 | 866.3400 | 1 | 4 |
| NHZ | Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus | 866.3400 | 1 | 0 |
| OAX | Plasmodium Spp. Detection Reagents | 866.3402 | 2 | 1 |
| GOE | Antisera, Fluorescent, Poliovirus 1-3 | 866.3405 | 1 | 7 |
| GOF | Antisera, Neutralization, Poliovirus 1-3 | 866.3405 | 1 | 0 |
| GOG | Antisera, Cf, Poliovirus 1-3 | 866.3405 | 1 | 3 |
| GOH | Antigens, Cf (Including Cf Control), Poliovirus 1-3 | 866.3405 | 1 | 0 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 866.3405 | 1 | 33 |
| GSY | Antisera, Fluorescent, All Globulins, Proteus Spp. | 866.3410 | 1 | 0 |
| GSZ | Antigens, Febrile (Weil-Felix), All Groups | 866.3410 | 1 | 3 |
| GSR | Antisera, Fluorescent, Pseudomonas Pseudomallei | 866.3415 | 2 | 0 |
| GSS | Antisera, Fluorescent, Pseudomonas Aeruginosa | 866.3415 | 2 | 1 |
| GST | Antiserum, Pseudomonas Pseudomallei | 866.3415 | 2 | 0 |
| GOI | Antiserum, Fluorescent, Rabies Virus | 866.3460 | 2 | 2 |
| GPX | Antisera, Neutralizion, Reovirus 1-3 | 866.3470 | 1 | 0 |
| GPY | Antisera, Hai, Reovirus 1-3 | 866.3470 | 1 | 0 |
| GPZ | Antisera, Cf, Reovirus 1-3 | 866.3470 | 1 | 0 |
| GQA | Antigens, Ha (Including Ha Control), Reovirus 1-3 | 866.3470 | 1 | 0 |
| GQB | Antigens, Cf (Including Cf Control), Reovirus 1-3 | 866.3470 | 1 | 0 |
| GQF | Antiserum, Neutralization, Respiratory Syncytial Virus | 866.3480 | 1 | 0 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 866.3480 | 1 | 32 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 866.3480 | 1 | 23 |
| MCE | Respiratory Syncytial Virus - Elisa | 866.3480 | 1 | 2 |
| NHY | Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus | 866.3480 | 1 | 0 |
| GQE | Antisera, Neutralization, All Types, Rhinovirus | 866.3490 | 1 | 0 |
| GPJ | Antiserum, Fluorescent, Q Fever | 866.3500 | 1 | 2 |
| GPK | Antiserum, Rickettsial Pox | 866.3500 | 1 | 0 |
| GPM | Antiserum, Murine Typhus Fever | 866.3500 | 1 | 1 |
| GPN | Antiserum, Typhus Fever | 866.3500 | 1 | 1 |
| GPO | Antigen, Cf, Typhus Fever Group | 866.3500 | 1 | 1 |
| GPP | Antiserum, Rocky Mountain Spotted Fever | 866.3500 | 1 | 1 |
| GPQ | Antigen, Cf, Spotted Fever Group | 866.3500 | 1 | 0 |
| GPR | Antiserum, Cf, Q Fever | 866.3500 | 1 | 0 |
| GPS | Antigen, Cf, Q Fever | 866.3500 | 1 | 1 |
| LSQ | Reagent, Rickettsia Serological | 866.3500 | 1 | 4 |
| OVF | Assay, Direct, Nucleic Acid Amplification, Q Fever | 866.3500 | 1 | 1 |
| GOJ | Antisera, Neutralization, Rubella | 866.3510 | 2 | 0 |
| GOK | Antisera, Hai (Including Hai Control), Rubella | 866.3510 | 2 | 11 |
| GOL | Antigen, Ha (Including Ha Control), Rubella | 866.3510 | 2 | 21 |
| GOM | Antisera, Cf, Rubella | 866.3510 | 2 | 2 |
| GON | Antigen, Cf (Including Cf Control), Rubella | 866.3510 | 2 | 5 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 866.3510 | 2 | 94 |
| LQN | Latex Agglutination Assay, Rubella | 866.3510 | 2 | 13 |
| LSD | Rubella, Other Assays | 866.3510 | 2 | 0 |
| LSJ | Antigen, Rubella, Other | 866.3510 | 2 | 0 |
| OMI | Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv | 866.3510 | 2 | 2 |
| OPL | Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus | 866.3510 | 2 | 3 |
| OPM | Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 | 866.3510 | 2 | 1 |
| PUQ | Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm | 866.3510 | 2 | 1 |
| GRE | Antiserum, Fluorescent, Rubeola | 866.3520 | 1 | 4 |
| GRF | Antiserum, Cf, Rubeola | 866.3520 | 1 | 2 |
| GRG | Antiserum, Hai, Rubeola | 866.3520 | 1 | 0 |
| GRH | Antigen, Ha (Including Ha Control), Rubeola | 866.3520 | 1 | 0 |
| GRI | Antiserum, Neutralization, Rubeola | 866.3520 | 1 | 0 |
| GRJ | Antigen, Cf, (Including Cf Control), Rubeola | 866.3520 | 1 | 2 |
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 866.3520 | 1 | 11 |
| PCL | Enzyme Linked Immunoabsorbent Assay, Rubeola Igm | 866.3520 | 1 | 1 |
| GNC | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. | 866.3550 | 2 | 60 |
| GOO | Antisera, Fluorescent, All Globulins, Salmonella Spp. | 866.3550 | 2 | 0 |
| GRL | Antigens, All Groups, Salmonella Spp. | 866.3550 | 2 | 2 |
| GRM | Antisera, All Groups, Salmonella Spp. | 866.3550 | 2 | 69 |
| LSM | Dna-Reagents, Salmonella Spp. | 866.3550 | 2 | 0 |
| GNH | Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | 866.3600 | 1 | 2 |
| GTA | Antisera, All, Serratia Marcesans | 866.3630 | 1 | 0 |
| GNB | Antisera, All Types, Shigella Spp. | 866.3660 | 2 | 41 |
| GTD | Antisera, Fluorescent, All Globulins, Shigella Spp. | 866.3660 | 2 | 0 |
| LIA | Antigens, All Groups, Shigella Spp. | 866.3660 | 2 | 1 |
| LSN | Dna-Reagents, Shigella Spp. | 866.3660 | 2 | 0 |
| GMA | Antisera, Fluorescent, Sporothrix Schenekii | 866.3680 | 1 | 1 |
| GTN | Antisera, Fluorescent, All Types, Staphylococcus Spp. | 866.3700 | 1 | 4 |
| LHJ | Staphylococcus Aureus Protein A Insoluble | 866.3700 | 1 | 3 |
| LHT | Staphylococcus Aureus Somatic Antigens | 866.3700 | 1 | 13 |
| MCS | Dna-Probe, Staphylococcus Aureus | 866.3700 | 1 | 1 |
| NXX | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus | 866.3700 | 1 | 4 |
| GTO | Anti-Streptokinase | 866.3720 | 1 | 0 |
| GTP | Exoenzymes, Multiple, Streptococcal | 866.3720 | 1 | 3 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 866.3720 | 1 | 37 |
| GTR | Antideoxyribonuclease, Streptococcus Spp. | 866.3720 | 1 | 1 |
| LHW | Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment | 866.3720 | 1 | 4 |
| GTX | Antisera, Fluorescent, All Groups, Streptococcus Spp. | 866.3740 | 1 | 2 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 866.3740 | 1 | 43 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 866.3740 | 1 | 105 |
| GWB | Antisera, Fluorescent, All Types, Streptococcus Pneumoniae | 866.3740 | 1 | 2 |
| GWC | Antisera, All Types, Streptococcus Pneumoniae | 866.3740 | 1 | 9 |
| MCT | Dna-Probe, Strep Pneumoniae | 866.3740 | 1 | 1 |
| MDK | Dna-Probe, Reagents, Streptococcal | 866.3740 | 1 | 4 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 866.3740 | 1 | 18 |
| OAH | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis | 866.3740 | 1 | 4 |
| OYZ | Group A Streptococcus Nucleic Acid Amplification Assay System | 866.3740 | 1 | 1 |
| GLZ | Antigens, If, Toxoplasma Gondii | 866.3780 | 2 | 18 |
| GMM | Antigens, Iha, Toxoplasma Gondii | 866.3780 | 2 | 8 |
| GMN | Antigens, Cf, Toxoplasma Gondii | 866.3780 | 2 | 3 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 866.3780 | 2 | 106 |
| LJK | Antisera, If, Toxoplasma Gondii | 866.3780 | 2 | 6 |
| LLA | Direct Agglutination Test, Toxoplasma Gondii | 866.3780 | 2 | 4 |
| LYF | Pneumocystis Carinii | 866.3780 | 2 | 7 |
| GMP | Antisera, Control For Nontreponemal Tests | 866.3820 | 2 | 9 |
| GMQ | Antigens, Nontreponemal, All | 866.3820 | 2 | 32 |
| GMR | Sera, Reactive And Non-Specific Control, Fta-Abs Test | 866.3830 | 2 | 0 |
| GMS | Anti-Human Globulin, Fta-Abs Test | 866.3830 | 2 | 3 |
| GMT | Antigens, Ha, Treponema Pallidum | 866.3830 | 2 | 9 |
| GMW | Test, Sorbent, Fta-Abs | 866.3830 | 2 | 0 |
| GMX | Antisera, Fluorescent Antibody For Fta-Abs Test | 866.3830 | 2 | 0 |
| JWL | Antigen, Treponema Pallidum For Fta-Abs Test | 866.3830 | 2 | 4 |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 866.3830 | 2 | 35 |
| LSR | Reagent, Borrelia Serological Reagent | 866.3830 | 2 | 111 |
| MYR | Test, Donor, Syphilis, Antigens, Treponemal | 866.3830 | 2 | 0 |
| GPG | Antigen, Latex Agglutination, Trichinella Spiralis | 866.3850 | 1 | 2 |
| GPH | Antiserum, Bentonite Flocculation, Trichinella Spiralis | 866.3850 | 1 | 0 |
| GPI | Antigen, Bentonite Flocculation, Trichinella Spiralis | 866.3850 | 1 | 0 |
| MDT | Elisa, Trichinella Spiralis | 866.3850 | 1 | 0 |
| GND | Antigen, Iha, T. Cruzi | 866.3870 | 1 | 0 |
| GNE | Antigen, Latex Agglutination, T. Cruzi | 866.3870 | 1 | 1 |
| GNF | Antigen, Cf, T. Cruzi | 866.3870 | 1 | 0 |
| LOO | Reagent, Leishmanii Serological | 866.3870 | 1 | 2 |
| MIU | Enzyme Linked Immunosorbent Assay, T. Cruzi | 866.3870 | 1 | 6 |
| MIV | Immunofluorescent Assay, T. Cruzi | 866.3870 | 1 | 0 |
| OUZ | Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids | 866.3870 | 1 | 1 |
| PIT | Leishmania Spp. Antigen Detection Assay | 866.3870 | 1 | 1 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | 866.3900 | 2 | 10 |
| GQX | Antiserum, Cf, Varicella-Zoster | 866.3900 | 2 | 11 |
| LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 866.3900 | 2 | 17 |
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | 866.3920 | 2 | 30 |
| QCH | Assayed Quality Control Material For Clinical Microbiology Assays | 866.3920 | 2 | 1 |
| QTM | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening. | 866.3920 | 2 | 0 |
| GSQ | Antiserum, Vibrio Cholerae, All Varieties | 866.3930 | 2 | 3 |
| QFO | Zika Virus Serological Reagents | 866.3935 | 2 | 4 |
| NOP | Elisa, Antibody, West Nile Virus | 866.3940 | 2 | 10 |
| OSU | Dengue Serological Reagents | 866.3945 | 2 | 1 |
| QCU | Dengue Virus Antigen Assay | 866.3945 | 2 | 1 |
| OZB | Dengue Nucleic Acid Amplification Assay (Naat) | 866.3946 | 2 | 1 |
| MZF | Test, Hiv Detection | 866.3956 | 2 | 0 |
| QSU | Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test | 866.3956 | 2 | 0 |
| QST | Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test | 866.3957 | 2 | 0 |
| QSV | Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test | 866.3957 | 2 | 0 |
| QUM | Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test | 866.3958 | 2 | 0 |
| PII | Candida Species Nucleic Acid Detection System | 866.3960 | 2 | 3 |
| QBX | Direct Blood Bacterial Nucleic Acid Detection System | 866.3960 | 2 | 2 |
| QMV | Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness | 866.3966 | 2 | 3 |
| SBT | Device To Detect Microbial Colonization Directly From Clinical Specimens. | 866.3967 | 2 | 1 |
| PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | 866.3970 | 2 | 4 |
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 866.3975 | 2 | 11 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 866.3980 | 2 | 78 |
| OEM | Human Metapneumovirus (Hmpv) Rna Assay System | 866.3980 | 2 | 6 |
| OEP | Influenza A Virus Subtype Differentiation Nucleic Acid Assay | 866.3980 | 2 | 1 |
| OMG | Antisera, Fluorescent, Human Metapneumovirus | 866.3980 | 2 | 4 |
| OOU | Parainfluenza Multiplex Nucleic Acid Assay | 866.3980 | 2 | 5 |
| OTG | Non-Sars Coronavirus Multiplex Nucleic Acid Assay | 866.3980 | 2 | 0 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | 866.3980 | 2 | 20 |
| OZX | Mycoplasma Pneumoniae Dna Assay System | 866.3980 | 2 | 3 |
| OZY | Chlamydophila Pneumoniae Dna Assay System | 866.3980 | 2 | 0 |
| OZZ | Bordetella Pertussis Dna Assay System | 866.3980 | 2 | 9 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 866.3981 | 2 | 32 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | 866.3981 | 2 | 11 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 866.3982 | 2 | 8 |
| QWR | Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings | 866.3982 | 2 | 3 |
| QVP | Sars-Cov-2 Serology Test | 866.3983 | 2 | 5 |
| QWB | Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens | 866.3984 | 2 | 2 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 866.3984 | 2 | 13 |
| QBH | Lower Respiratory Microbial Nucleic Acid Detection System | 866.3985 | 2 | 2 |
| QDP | Respiratory Panel | 866.3985 | 2 | 2 |
| SBZ | Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users | 866.3986 | 2 | 1 |
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | 866.3987 | 2 | 11 |
| QSN | Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System | 866.3988 | 2 | 1 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 866.3990 | 2 | 37 |
| PCI | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System | 866.3990 | 2 | 5 |
| PIQ | Reagents For Detection Of Norovirus Nucleic Acid | 866.3990 | 2 | 1 |
