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Microbiology devices
418 product codes reviewed by the Microbiology panel. 6,965 510(k) clearances and 1,455 recalls in the FDA data, 54% of those recalls name a 510(k).
97510(k)s in 12 months
68recalls in 12 months
786recalls that name a 510(k)
Active product codes, Class II
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 2 | 10 | 3 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 2 | 4 | 6 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 | 3 | 5 |
| JTN | Susceptibility Test Discs, Antimicrobial | 2 | 6 | 1 |
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | 2 | 7 | 0 |
| QPO | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | 2 | 0 | 6 |
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | 2 | 5 | 0 |
| SEI | Qualitative And Quantitative Hepatitis B Virus Antibody Assays | 2 | 4 | 0 |
| LSR | Reagent, Borrelia Serological Reagent | 2 | 2 | 1 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 2 | 0 | 3 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | 3 | 0 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 2 | 3 | 0 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 2 | 3 | 0 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 2 | 3 | 0 |
| SAN | Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | 2 | 3 | 0 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 | 1 | 1 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 2 | 2 | 0 |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | 0 | 2 |
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | 2 | 2 | 0 |
| MZO | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | 2 | 2 | 0 |
| NGZ | Susceptibility Test Plate, Antifungal | 2 | 0 | 2 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | 2 | 1 | 1 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 2 | 1 | 1 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | 2 | 0 |
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 2 | 2 | 0 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | 2 | 0 |
| QSN | Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System | 2 | 0 | 2 |
| QVP | Sars-Cov-2 Serology Test | 2 | 2 | 0 |
| GRM | Antisera, All Groups, Salmonella Spp. | 2 | 0 | 1 |
| GTJ | Antisera, All Groups, N. Meningitidis | 2 | 0 | 1 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 2 | 0 | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | 1 | 0 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | 0 | 1 |
| LHK | Antigen, Id, Candida Albicans | 2 | 0 | 1 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 2 | 1 | 0 |
| LRF | Candida Spp., Direct Antigen, Id | 2 | 0 | 1 |
| LTW | Susceptibility Test Cards, Antimicrobial | 2 | 0 | 1 |
| MHI | Giardia Spp. | 2 | 0 | 1 |
| NHT | Assay, Nucleic Acid Amplification, Bacillus Anthracis | 2 | 1 | 0 |
| OZZ | Bordetella Pertussis Dna Assay System | 2 | 1 | 0 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 2 | 1 | 0 |
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | 2 | 1 | 0 |
| PEU | System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen | 2 | 0 | 1 |
| POC | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen | 2 | 1 | 0 |
| PPU | Microbial Colony Image Assessment System | 2 | 1 | 0 |
| QCH | Assayed Quality Control Material For Clinical Microbiology Assays | 2 | 1 | 0 |
| QDP | Respiratory Panel | 2 | 0 | 1 |
| QPS | Immunoassay For Host Biomarkers Of Infection | 2 | 1 | 0 |
| QUT | Deformability Cytometry For Sepsis Risk Assessment | 2 | 1 | 0 |
| QWB | Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens | 2 | 1 | 0 |
| QXA | Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection | 2 | 1 | 0 |
| SEP | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | 2 | 1 | 0 |
| SIA | Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test | 2 | 1 | 0 |
| SIH | Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay | 2 | 1 | 0 |
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