Microbiology

Page 3 of 3

Code	Device name	Class	21 CFR	510(k) (3y)
OQW	2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Det	Class 2	21 CFR 866.3332	10
OSU	Dengue Serological Reagents	Class 2	21 CFR 866.3945	1
OTG	Non-Sars Coronavirus Multiplex Nucleic Acid Assay	Class 2	21 CFR 866.3980
OUC	Norovirus Serological Reagent	Class 2	21 CFR 866.3395	1
OUS	Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible St	Class 1	21 CFR 866.2050	2
OUZ	Nucleic Amplification Assays For The Detection Of Leishmania Nucleic A	Class 1	21 CFR 866.3870	1
OVF	Assay, Direct, Nucleic Acid Amplification, Q Fever	Class 1	21 CFR 866.3500	1
OWF	Immunohistochemical Assay, Helicobacter Pylori	Class 1	21 CFR 866.3110	1
OYP	Anti-Jcv Antibody Detection Assay	Class 2	21 CFR 866.3336	2
OYZ	Group A Streptococcus Nucleic Acid Amplification Assay System	Class 1	21 CFR 866.3740	1
OZA	Test, Urea Adult And Pediatric (Breath),	Class 3	21 CFR 866.3110
OZB	Dengue Nucleic Acid Amplification Assay (Naat)	Class 2	21 CFR 866.3946	1
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Class 2	21 CFR 866.3980	20
OZN	C. Difficile Toxin Gene Amplification Assay	Class 2	21 CFR 866.3130	18
OZX	Mycoplasma Pneumoniae Dna Assay System	Class 2	21 CFR 866.3980	3
OZY	Chlamydophila Pneumoniae Dna Assay System	Class 2	21 CFR 866.3980
OZZ	Bordetella Pertussis Dna Assay System	Class 2	21 CFR 866.3980	9
PAB	Cytomegalovirus (Cmv) Dna Quantitative Assay	Class 2	21 CFR 866.3180	3
PAM	Gram-Positive Bacteria And Their Resistance Markers	Class 2	21 CFR 866.3365	7
PBK	Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set	Class 2	21 CFR 866.3315	5
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay Sys	Class 2	21 CFR 866.3990	38
PCI	Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay Sy	Class 2	21 CFR 866.3990	5
PCL	Enzyme Linked Immunoabsorbent Assay, Rubeola Igm	Class 1	21 CFR 866.3520	1
PEN	Gram-Negative Bacteria And Associated Resistance Markers	Class 2	21 CFR 866.3365	11
PEO	Fungal Organisms, Nucleic Acid-Based Assay	Class 2	21 CFR 866.3365	2
PEU	System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resist	Class 2	21 CFR 866.3373	2
PEX	System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cu	Class 2	21 CFR 866.3361	5
PGH	Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel	Class 2	21 CFR 866.3307	3
PGI	Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And	Class 2	21 CFR 866.3309	9
PGV	Anti-Phospholipase A2 Receptor	Class 2	21 CFR 866.5780	2
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplificat	Class 2	21 CFR 866.2680	15
PII	Candida Species Nucleic Acid Detection System	Class 2	21 CFR 866.3960	3
PIQ	Reagents For Detection Of Norovirus Nucleic Acid	Class 2	21 CFR 866.3990	1
PIT	Leishmania Spp. Antigen Detection Assay	Class 1	21 CFR 866.3870	1
PLO	Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection Syst	Class 2	21 CFR 866.3970	4
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplif	Class 2	21 CFR 866.3920	32
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Spe	Class 2	21 CFR 866.3215	5
PMY	System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptib	Class 2	21 CFR 866.1640	3
POC	System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance	Class 2	21 CFR 866.1640	4
PPU	Microbial Colony Image Assessment System	Class 2	21 CFR 866.2190	3
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Class 2	21 CFR 866.3975	12
PQZ	Gbs Culture Media, Selective And Differential	Class 1	21 CFR 866.2360	4
PRA	Variola Virus Nucleic Acid-Based Detection Assay	Class 2	21 CFR 866.3316	1
PRE	Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers	Class 2	21 CFR 866.3215	4
PRH	Positive Blood Culture Identification And Ast Kit	Class 2	21 CFR 866.1650	2
PRI	Procalcitonin Assay	Class 2	21 CFR 866.3215	8
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Class 2	21 CFR 866.3328	72
PTF	Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill P	Class 2	21 CFR 866.3215	4
PTJ	Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured	Class 2	21 CFR 866.1640	3
PUQ	Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm	Class 2	21 CFR 866.3510	1
PVQ	Rickettsia Spp. Nucleic Acid Based Detection Assay	Class 2	21 CFR 866.3316	1
PYN	Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodiu	Class 2	21 CFR 866.3367	1
QAA	Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specim	Class 2	21 CFR 866.3376	1
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Class 2	21 CFR 866.2950	17
QBH	Lower Respiratory Microbial Nucleic Acid Detection System	Class 2	21 CFR 866.3985	2
QBN	Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured I	Class 2	21 CFR 866.3378	4
QBQ	System, Microbial Growth Monitor Of Normally Sterile Body Fluid Cultur	Class 1	21 CFR 866.2560	1
QBX	Direct Blood Bacterial Nucleic Acid Detection System	Class 2	21 CFR 866.3960	2
QCH	Assayed Quality Control Material For Clinical Microbiology Assays	Class 2	21 CFR 866.3920	1
QCU	Dengue Virus Antigen Assay	Class 2	21 CFR 866.3945	1
QDP	Respiratory Panel	Class 2	21 CFR 866.3985	2
QDZ	Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Co	Class 2	21 CFR 866.3181	2
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing S	Class 2	21 CFR 866.3393	24
QFA	Assay For Detection Of Proteases In Chronic Wounds	Class 2	21 CFR 866.3231	1
QFO	Zika Virus Serological Reagents	Class 2	21 CFR 866.3935	4
QFS	Monocyte Distribution Width Quantitative Measurement For Sepsis Risk A	Class 2	21 CFR 866.3215	1
QGN	Lateral Flow Immunochromatography Assay For Host Infection Biomarkers	Class 2	21 CFR 866.3230	2
QHM	Serology Tests Used For Infectious Disease Screening Of Blood And Plas	Class U	21 CFR 610.40
QHO	Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And	Class U	21 CFR 610.40
QID	Device To Detect Antigens Of Biothreat Microbial Agents In Human Clini	Class 2	21 CFR 866.4002	1
QIG	Quality Control Material, Genetics, Rna	Class 2	21 CFR 866.5910
QIV	Culture-Based Short-Term Incubation Antimicrobial Resistance Assay	Class 2	21 CFR 866.1655	1
QLX	Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr V	Class 2	21 CFR 866.3183	4
QMC	Transport Medium, Notified Per The Vtm Guidance	Class 1	21 CFR 866.2390
QMI	Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk)	Class 2	21 CFR 866.3183	2
QMV	Device To Detect And Identify Selected Microbial Agents That Cause Acu	Class 2	21 CFR 866.3966	3
QNJ	Mass Spectrometry, Microorganism Identification, Blood Culture	Class 2	21 CFR 866.3378	2
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov	Class 2	21 CFR 866.3981	33
QPO	Device To Preserve And Stabilize Relative Abundances Of Microbial Nucl	Class 2	21 CFR 866.2952	1
QPS	Immunoassay For Host Biomarkers Of Infection	Class 2	21 CFR 866.3215	4
QQV	Automated System For Sample Preparation And Identification Of Microorg	Class 2	21 CFR 866.3378	4
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Class 2	21 CFR 866.3981	11
QQY	Culture Plate Imaging System For Qualitative Assessment Of Resistant O	Class 2	21 CFR 866.2190	2
QSN	Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System	Class 2	21 CFR 866.3988	1
QST	Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test	Class 2	21 CFR 866.3957
QSU	Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test	Class 2	21 CFR 866.3956
QSV	Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test	Class 2	21 CFR 866.3957
QTM	Assayed External Control Material For Microbiology Nucleic Acid Amplif	Class 2	21 CFR 866.3920
QUM	Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test	Class 2	21 CFR 866.3958
QUT	Deformability Cytometry For Sepsis Risk Assessment	Class 2	21 CFR 866.3215	3
QUU	Simple In Vitro Diagnostic Device For The Detection Of Secreted Protei	Class 2	21 CFR 866.3046	2
QVF	Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Target	Class 2	21 CFR 866.3982	9
QVP	Sars-Cov-2 Serology Test	Class 2	21 CFR 866.3983	5
QWB	Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Spe	Class 2	21 CFR 866.3984	3
QWR	Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets F	Class 2	21 CFR 866.3982	3
QXA	Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respira	Class 2	21 CFR 866.3230	2
QYA	System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) C	Class 2	21 CFR 866.3385	2
QYT	Over-The-Counter Covid-19 Antigen Test	Class 2	21 CFR 866.3984	14
QZX	Positive Blood Culture Processor For Inoculum Preparation Used For Ant	Class 2	21 CFR 866.1650	3
SAN	Automated Antimicrobial Susceptibility Test System For Positive Blood	Class 2	21 CFR 866.1650	8
SBP	Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic	Class 2	21 CFR 866.3171	1
SBT	Device To Detect Microbial Colonization Directly From Clinical Specime	Class 2	21 CFR 866.3967	1
SBZ	Test For Detection Of Antibodies Associated With Syphilis Performed By	Class 2	21 CFR 866.3986	1
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Class 2	21 CFR 866.3987	12
SCU	Dna And Rna Oncology Controls	Class 2	21 CFR 866.5910
SCX	Immunoassay For Host Biomarkers Of Sepsis	Class 2	21 CFR 866.3215	1
SEA	Test For Detection Of Microorganism(S) Causing Sexually Transmitted In	Class 2	21 CFR 866.3386	1
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Class 2	21 CFR 866.3173	4
SEP	Device For Home Collection And Transport Of Vaginal Specimens By Lay U	Class 2	21 CFR 866.2920	2
SIA	Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection T	Class 2	21 CFR 866.3984	1
SIH	Device For Home Collection And Transport Of Specimens By Lay Users For	Class 2	21 CFR 866.2920	1