Immunology

Page 2 of 2

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