| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Det | 第 2 类 | 21 CFR 866.3332 | 10 |
| OSU | Dengue Serological Reagents | 第 2 类 | 21 CFR 866.3945 | 1 |
| OTG | Non-Sars Coronavirus Multiplex Nucleic Acid Assay | 第 2 类 | 21 CFR 866.3980 | |
| OUC | Norovirus Serological Reagent | 第 2 类 | 21 CFR 866.3395 | 1 |
| OUS | Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible St | 第 1 类 | 21 CFR 866.2050 | 2 |
| OUZ | Nucleic Amplification Assays For The Detection Of Leishmania Nucleic A | 第 1 类 | 21 CFR 866.3870 | 1 |
| OVF | Assay, Direct, Nucleic Acid Amplification, Q Fever | 第 1 类 | 21 CFR 866.3500 | 1 |
| OWF | Immunohistochemical Assay, Helicobacter Pylori | 第 1 类 | 21 CFR 866.3110 | 1 |
| OYP | Anti-Jcv Antibody Detection Assay | 第 2 类 | 21 CFR 866.3336 | 2 |
| OYZ | Group A Streptococcus Nucleic Acid Amplification Assay System | 第 1 类 | 21 CFR 866.3740 | 1 |
| OZA | Test, Urea Adult And Pediatric (Breath), | 第 3 类 | 21 CFR 866.3110 | |
| OZB | Dengue Nucleic Acid Amplification Assay (Naat) | 第 2 类 | 21 CFR 866.3946 | 1 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | 第 2 类 | 21 CFR 866.3980 | 20 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 第 2 类 | 21 CFR 866.3130 | 18 |
| OZX | Mycoplasma Pneumoniae Dna Assay System | 第 2 类 | 21 CFR 866.3980 | 3 |
| OZY | Chlamydophila Pneumoniae Dna Assay System | 第 2 类 | 21 CFR 866.3980 | |
| OZZ | Bordetella Pertussis Dna Assay System | 第 2 类 | 21 CFR 866.3980 | 9 |
| PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | 第 2 类 | 21 CFR 866.3180 | 3 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 第 2 类 | 21 CFR 866.3365 | 7 |
| PBK | Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set | 第 2 类 | 21 CFR 866.3315 | 5 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay Sys | 第 2 类 | 21 CFR 866.3990 | 38 |
| PCI | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay Sy | 第 2 类 | 21 CFR 866.3990 | 5 |
| PCL | Enzyme Linked Immunoabsorbent Assay, Rubeola Igm | 第 1 类 | 21 CFR 866.3520 | 1 |
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | 第 2 类 | 21 CFR 866.3365 | 11 |
| PEO | Fungal Organisms, Nucleic Acid-Based Assay | 第 2 类 | 21 CFR 866.3365 | 2 |
| PEU | System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resist | 第 2 类 | 21 CFR 866.3373 | 2 |
| PEX | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cu | 第 2 类 | 21 CFR 866.3361 | 5 |
| PGH | Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel | 第 2 类 | 21 CFR 866.3307 | 3 |
| PGI | Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And | 第 2 类 | 21 CFR 866.3309 | 9 |
| PGV | Anti-Phospholipase A2 Receptor | 第 2 类 | 21 CFR 866.5780 | 2 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplificat | 第 2 类 | 21 CFR 866.2680 | 15 |
| PII | Candida Species Nucleic Acid Detection System | 第 2 类 | 21 CFR 866.3960 | 3 |
| PIQ | Reagents For Detection Of Norovirus Nucleic Acid | 第 2 类 | 21 CFR 866.3990 | 1 |
| PIT | Leishmania Spp. Antigen Detection Assay | 第 1 类 | 21 CFR 866.3870 | 1 |
| PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection Syst | 第 2 类 | 21 CFR 866.3970 | 4 |
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplif | 第 2 类 | 21 CFR 866.3920 | 32 |
| PMT | Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Spe | 第 2 类 | 21 CFR 866.3215 | 5 |
| PMY | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptib | 第 2 类 | 21 CFR 866.1640 | 3 |
| POC | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance | 第 2 类 | 21 CFR 866.1640 | 4 |
| PPU | Microbial Colony Image Assessment System | 第 2 类 | 21 CFR 866.2190 | 3 |
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 第 2 类 | 21 CFR 866.3975 | 12 |
| PQZ | Gbs Culture Media, Selective And Differential | 第 1 类 | 21 CFR 866.2360 | 4 |
| PRA | Variola Virus Nucleic Acid-Based Detection Assay | 第 2 类 | 21 CFR 866.3316 | 1 |
| PRE | Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers | 第 2 类 | 21 CFR 866.3215 | 4 |
| PRH | Positive Blood Culture Identification And Ast Kit | 第 2 类 | 21 CFR 866.1650 | 2 |
| PRI | Procalcitonin Assay | 第 2 类 | 21 CFR 866.3215 | 8 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 第 2 类 | 21 CFR 866.3328 | 72 |
| PTF | Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill P | 第 2 类 | 21 CFR 866.3215 | 4 |
| PTJ | Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured | 第 2 类 | 21 CFR 866.1640 | 3 |
| PUQ | Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm | 第 2 类 | 21 CFR 866.3510 | 1 |
| PVQ | Rickettsia Spp. Nucleic Acid Based Detection Assay | 第 2 类 | 21 CFR 866.3316 | 1 |
| PYN | Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodiu | 第 2 类 | 21 CFR 866.3367 | 1 |
| QAA | Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specim | 第 2 类 | 21 CFR 866.3376 | 1 |
| QBD | Microbial Nucleic Acid Storage And Stabilization Device | 第 2 类 | 21 CFR 866.2950 | 17 |
| QBH | Lower Respiratory Microbial Nucleic Acid Detection System | 第 2 类 | 21 CFR 866.3985 | 2 |
| QBN | Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured I | 第 2 类 | 21 CFR 866.3378 | 4 |
| QBQ | System, Microbial Growth Monitor Of Normally Sterile Body Fluid Cultur | 第 1 类 | 21 CFR 866.2560 | 1 |
| QBX | Direct Blood Bacterial Nucleic Acid Detection System | 第 2 类 | 21 CFR 866.3960 | 2 |
| QCH | Assayed Quality Control Material For Clinical Microbiology Assays | 第 2 类 | 21 CFR 866.3920 | 1 |
| QCU | Dengue Virus Antigen Assay | 第 2 类 | 21 CFR 866.3945 | 1 |
| QDP | Respiratory Panel | 第 2 类 | 21 CFR 866.3985 | 2 |
| QDZ | Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Co | 第 2 类 | 21 CFR 866.3181 | 2 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing S | 第 2 类 | 21 CFR 866.3393 | 24 |
| QFA | Assay For Detection Of Proteases In Chronic Wounds | 第 2 类 | 21 CFR 866.3231 | 1 |
| QFO | Zika Virus Serological Reagents | 第 2 类 | 21 CFR 866.3935 | 4 |
| QFS | Monocyte Distribution Width Quantitative Measurement For Sepsis Risk A | 第 2 类 | 21 CFR 866.3215 | 1 |
| QGN | Lateral Flow Immunochromatography Assay For Host Infection Biomarkers | 第 2 类 | 21 CFR 866.3230 | 2 |
| QHM | Serology Tests Used For Infectious Disease Screening Of Blood And Plas | 第 U 类 | 21 CFR 610.40 | |
| QHO | Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And | 第 U 类 | 21 CFR 610.40 | |
| QID | Device To Detect Antigens Of Biothreat Microbial Agents In Human Clini | 第 2 类 | 21 CFR 866.4002 | 1 |
| QIG | Quality Control Material, Genetics, Rna | 第 2 类 | 21 CFR 866.5910 | |
| QIV | Culture-Based Short-Term Incubation Antimicrobial Resistance Assay | 第 2 类 | 21 CFR 866.1655 | 1 |
| QLX | Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr V | 第 2 类 | 21 CFR 866.3183 | 4 |
| QMC | Transport Medium, Notified Per The Vtm Guidance | 第 1 类 | 21 CFR 866.2390 | |
| QMI | Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) | 第 2 类 | 21 CFR 866.3183 | 2 |
| QMV | Device To Detect And Identify Selected Microbial Agents That Cause Acu | 第 2 类 | 21 CFR 866.3966 | 3 |
| QNJ | Mass Spectrometry, Microorganism Identification, Blood Culture | 第 2 类 | 21 CFR 866.3378 | 2 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov | 第 2 类 | 21 CFR 866.3981 | 33 |
| QPO | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucl | 第 2 类 | 21 CFR 866.2952 | 1 |
| QPS | Immunoassay For Host Biomarkers Of Infection | 第 2 类 | 21 CFR 866.3215 | 4 |
| QQV | Automated System For Sample Preparation And Identification Of Microorg | 第 2 类 | 21 CFR 866.3378 | 4 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | 第 2 类 | 21 CFR 866.3981 | 11 |
| QQY | Culture Plate Imaging System For Qualitative Assessment Of Resistant O | 第 2 类 | 21 CFR 866.2190 | 2 |
| QSN | Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System | 第 2 类 | 21 CFR 866.3988 | 1 |
| QST | Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test | 第 2 类 | 21 CFR 866.3957 | |
| QSU | Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test | 第 2 类 | 21 CFR 866.3956 | |
| QSV | Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test | 第 2 类 | 21 CFR 866.3957 | |
| QTM | Assayed External Control Material For Microbiology Nucleic Acid Amplif | 第 2 类 | 21 CFR 866.3920 | |
| QUM | Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test | 第 2 类 | 21 CFR 866.3958 | |
| QUT | Deformability Cytometry For Sepsis Risk Assessment | 第 2 类 | 21 CFR 866.3215 | 3 |
| QUU | Simple In Vitro Diagnostic Device For The Detection Of Secreted Protei | 第 2 类 | 21 CFR 866.3046 | 2 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Target | 第 2 类 | 21 CFR 866.3982 | 9 |
| QVP | Sars-Cov-2 Serology Test | 第 2 类 | 21 CFR 866.3983 | 5 |
| QWB | Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Spe | 第 2 类 | 21 CFR 866.3984 | 3 |
| QWR | Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets F | 第 2 类 | 21 CFR 866.3982 | 3 |
| QXA | Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respira | 第 2 类 | 21 CFR 866.3230 | 2 |
| QYA | System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) C | 第 2 类 | 21 CFR 866.3385 | 2 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 第 2 类 | 21 CFR 866.3984 | 14 |
| QZX | Positive Blood Culture Processor For Inoculum Preparation Used For Ant | 第 2 类 | 21 CFR 866.1650 | 3 |
| SAN | Automated Antimicrobial Susceptibility Test System For Positive Blood | 第 2 类 | 21 CFR 866.1650 | 8 |
| SBP | Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic | 第 2 类 | 21 CFR 866.3171 | 1 |
| SBT | Device To Detect Microbial Colonization Directly From Clinical Specime | 第 2 类 | 21 CFR 866.3967 | 1 |
| SBZ | Test For Detection Of Antibodies Associated With Syphilis Performed By | 第 2 类 | 21 CFR 866.3986 | 1 |
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | 第 2 类 | 21 CFR 866.3987 | 12 |
| SCU | Dna And Rna Oncology Controls | 第 2 类 | 21 CFR 866.5910 | |
| SCX | Immunoassay For Host Biomarkers Of Sepsis | 第 2 类 | 21 CFR 866.3215 | 1 |
| SEA | Test For Detection Of Microorganism(S) Causing Sexually Transmitted In | 第 2 类 | 21 CFR 866.3386 | 1 |
| SEI | Qualitative And Quantitative Hepatitis B Virus Antibody Assays | 第 2 类 | 21 CFR 866.3173 | 4 |
| SEP | Device For Home Collection And Transport Of Vaginal Specimens By Lay U | 第 2 类 | 21 CFR 866.2920 | 2 |
| SIA | Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection T | 第 2 类 | 21 CFR 866.3984 | 1 |
| SIH | Device For Home Collection And Transport Of Specimens By Lay Users For | 第 2 类 | 21 CFR 866.2920 | 1 |