| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| MVE | Biosensor, Immunoassay, Myoglobin | 第 2 类 | 21 CFR 866.5680 | 1 |
| MVJ | Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | 第 2 类 | 21 CFR 866.5660 | 6 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 第 2 类 | 21 CFR 866.5660 | 40 |
| MVS | Kit, Typing, Hla-Dqb | 第 2 类 | 21 CFR 866.5660 | 1 |
| NBO | Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) | 第 2 类 | 21 CFR 866.5660 | 2 |
| NBS | Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) | 第 2 类 | 21 CFR 866.5660 | 3 |
| NBT | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | 第 2 类 | 21 CFR 866.5785 | 8 |
| NCW | System, Test, Her-2/Neu, Monitoring | 第 2 类 | 21 CFR 866.6010 | 3 |
| NHS | Assay, Genotype, Hiv Drug Resistance, In Vitro | 第 2 类 | 21 CFR 866.3950 | |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 第 2 类 | 21 CFR 866.5775 | 21 |
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Manage | 第 2 类 | 21 CFR 866.6010 | 12 |
| NIY | Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis | 第 2 类 | 21 CFR 866.5660 | 3 |
| NJF | Antibodies, Anti-Actin, Anti-Smooth Muscle | 第 2 类 | 21 CFR 866.5120 | 1 |
| NOE | Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 | 第 2 类 | 21 CFR 866.5600 | 8 |
| NPH | Antigen, Cartilage Oligomeric Matrix Protein (Comp) | 第 2 类 | 21 CFR 866.5775 | |
| NQD | Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | 第 2 类 | 21 CFR 866.5270 | 19 |
| NQI | System, Immunomagnetic, Circulating Cancer Cell, Enumeration | 第 2 类 | 21 CFR 866.6020 | 13 |
| NRI | Autoantibodies, Nuclear Pore Glycoprotein Gp210 | 第 2 类 | 21 CFR 866.5090 | 2 |
| NRX | Complement 4d (C4d) And Complement Receptor 1 (Cr1) | 第 2 类 | 21 CFR 866.5820 | |
| NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular C | 第 2 类 | 21 CFR 866.6030 | 2 |
| NST | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non | 第 2 类 | 21 CFR 866.5660 | 4 |
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluoresce | 第 2 类 | 21 CFR 866.4700 | 8 |
| NTV | Myeloperoxidase, Immunoassay, System, Test | 第 2 类 | 21 CFR 866.5600 | 2 |
| NTW | System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr | 第 2 类 | 21 CFR 866.4070 | 2 |
| NTY | System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of | 第 2 类 | 21 CFR 866.6010 | 1 |
| NUA | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Muta | 第 2 类 | 21 CFR 866.5900 | 12 |
| NUM | Autoantibodies, Nuclear Body Protein, Sp100 | 第 2 类 | 21 CFR 866.5090 | 1 |
| NVA | Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Me | 第 2 类 | 21 CFR 866.6010 | |
| NWG | Autoantibodies, Glutamic Acid Decarboxylase (Gad) | 第 2 类 | 21 CFR 866.5660 | 2 |
| NXO | Calprotectin, Fecal | 第 2 类 | 21 CFR 866.5180 | 15 |
| NYI | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expressio | 第 2 类 | 21 CFR 866.6040 | 10 |
| NYO | Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody | 第 2 类 | 21 CFR 866.5100 | 4 |
| OAU | Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular C | 第 2 类 | 21 CFR 866.6030 | 1 |
| OBE | Anti-Ss-A 52 Autoantibodies | 第 2 类 | 21 CFR 866.5100 | 3 |
| OBZ | Alpha-1-Antitrypsin Kit, Qualitative Phenotype | 第 2 类 | 21 CFR 866.5130 | 2 |
| OCN | Insulin Autoantibody Kit | 第 2 类 | 21 CFR 866.5660 | 1 |
| OEG | Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 23 | 第 2 类 | 21 CFR 866.5660 | 3 |
| OIF | Tyrosine Phosphatase (Ia-2) Autoantibody Assay | 第 2 类 | 21 CFR 866.5660 | 3 |
| OIU | Test, Epithelial Ovarian Tumor Associated Antigen (He4) | 第 2 类 | 21 CFR 866.6010 | 5 |
| OKM | Antibodies, Outer-Membrane Proteins | 第 2 类 | 21 CFR 866.5785 | 1 |
| OPN | Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/P | 第 2 类 | 21 CFR 866.5660 | 1 |
| OPX | Immunoglobulin A Kappa Heavy & Light Chain Combined | 第 2 类 | 21 CFR 866.5510 | 3 |
| OPY | Igal Heavy & Light Chain Combined | 第 2 类 | 21 CFR 866.5510 | |
| OQZ | Anti-Mutated Citrullinated Vimentin Igg | 第 2 类 | 21 CFR 866.5775 | 1 |
| OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 第 2 类 | 21 CFR 866.5660 | 1 |
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | 第 2 类 | 21 CFR 866.3860 | 10 |
| OVK | Cytokeratin Fragments 21-1 Eia Kit | 第 2 类 | 21 CFR 866.6010 | 3 |
| OVQ | Chronic Lymphocytic Leukemia Fish Probe Kit | 第 2 类 | 21 CFR 866.6040 | 2 |
| OWK | Early Growth Response 1 (Egr) Fish Probe Kit | 第 2 类 | 21 CFR 866.6040 | 1 |
| OWM | Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assess | 第 2 类 | 21 CFR 866.6040 | 1 |
| OXP | Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment | 第 2 类 | 21 CFR 866.6010 | 1 |
| OYL | Tryptase Assay System | 第 2 类 | 21 CFR 866.5760 | 2 |
| OYU | Dna-Probe Kit, Human Chromosome | 第 2 类 | 21 CFR 866.4700 | 3 |
| OYV | Inherited Nucleotide Repeat Disorder Dna Test | 第 2 类 | 21 CFR 866.5970 | 1 |
| OZF | Tissue Rna Preservative For Collection, Storage, And Transportation | 第 2 类 | 21 CFR 866.4070 | 1 |
| PAF | Voltage Gated Calcium Channel (Vgcc) Antibody Assay | 第 2 类 | 21 CFR 866.5660 | 1 |
| PCG | 21-Hydroxylase Antibody (21-Ohab) | 第 2 类 | 21 CFR 866.5660 | 2 |
| PCN | Immunoglobulin G Kappa Heavy And Light Chain Combined | 第 2 类 | 21 CFR 866.5510 | 3 |
| PCO | Immunoglobulin G Lambda Heavy And Light Chain Combined | 第 2 类 | 21 CFR 866.5510 | |
| PDE | Immunoglobulin M Kappa Heavy And Light Chain Combined | 第 2 类 | 21 CFR 866.5510 | 2 |
| PDF | Immunoglobulin M Lambda Heavy And Light Chain Combined | 第 2 类 | 21 CFR 866.5510 | |
| PET | Anti-Ss-A Ro60 Autoantibodies | 第 2 类 | 21 CFR 866.5100 | |
| PFF | High Throughput Dna Sequence Analyzer | 第 2 类 | 21 CFR 862.2265 | 2 |
| PFR | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Muta | 第 2 类 | 21 CFR 866.5900 | 1 |
| PFS | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Vari | 第 2 类 | 21 CFR 866.5900 | 1 |
| PFX | System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormali | 第 2 类 | 21 CFR 866.5920 | 2 |
| PHF | Zinc Transporter 8 Auto-Antibody | 第 2 类 | 21 CFR 866.5670 | 1 |
| PIV | Automated Indirect Immunofluorescence Microscope And Software-Assisted | 第 2 类 | 21 CFR 866.4750 | 2 |
| PJI | Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Tes | 第 2 类 | 21 CFR 866.5930 | 2 |
| PKB | Autosomal Recessive Carrier Screening Gene Mutation Detection System | 第 2 类 | 21 CFR 866.5940 | 1 |
| PNI | Aquaporin-4 Autoantibody | 第 2 类 | 21 CFR 866.5665 | 2 |
| PTA | Genetic Variant Detection And Health Risk Assessment System | 第 2 类 | 21 CFR 866.5950 | 5 |
| PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allerge | 第 2 类 | 21 CFR 866.5750 | |
| PZH | Serpina1 Variant Detection System | 第 2 类 | 21 CFR 866.5130 | 3 |
| PZJ | Lynch Syndrome Test System | 第 2 类 | 21 CFR 864.1866 | 4 |
| QAT | Brain Trauma Assessment Test | 第 2 类 | 21 CFR 866.5830 | 6 |
| QSA | Circulating Tumor Cell (Ctc) Enrichment Device | 第 2 类 | 21 CFR 866.6110 | 1 |
| QSE | AlzheimerS Disease Pathology Assessment Test | 第 2 类 | 21 CFR 866.5840 | 3 |
| QTE | Thymidine Kinase Activity | 第 2 类 | 21 CFR 866.6010 | 1 |
| QUE | Spinal Muscular Atrophy Newborn Screening Test System | 第 2 类 | 21 CFR 866.5980 | 1 |
| QUK | Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test | 第 2 类 | 21 CFR 866.5960 | |
| QVR | Multiplex Nucleic Acid Detection System For Biothreat Agents | 第 2 类 | 21 CFR 866.4000 | 3 |
| QXS | Chromogranin A | 第 2 类 | 21 CFR 866.6010 | 1 |
| QYO | Hematopoietic Cell Enrichment Kit | 第 2 类 | 21 CFR 866.6120 | 1 |
| SET | Immunoassay Blood Test For Amyloid Pathology Assessment | 第 2 类 | 21 CFR 866.5840 | 4 |
| SFC | Neurologic Disease Risk Assessment Molecular Test | 第 2 类 | 21 CFR 866.5850 | 1 |
| SGA | Biothreat Microbial Agent Nucleic Acid Detection Test | 第 2 类 | 21 CFR 866.4000 | 2 |
| SGG | Mass Spectrometric, Immunoglobulins (G, A, M, D, E) | 第 2 类 | 21 CFR 866.5510 | 1 |
| SGW | Device To Detect Antibodies To Hepatitis D Virus | 第 2 类 | 21 CFR 866.3176 | 1 |