Immunology

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Code	Device name	Class	21 CFR	510(k) (3y)
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Class 2	21 CFR 866.5510	29
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Class 2	21 CFR 866.5510	61
CFQ	Radioimmunoassay, Immunoglobulins (G, A, M)	Class 2	21 CFR 866.5510	12
CGM	Method, Immunodiffusion, Immunoglobulins (G, A, M)	Class 2	21 CFR 866.5510	4
CHN	Immunochemical, Ceruloplasmin	Class 2	21 CFR 866.5210	3
CZJ	Igd, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	8
CZK	Iga, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	1
CZL	Iga, Peroxidase, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510
CZM	Iga, Ferritin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	1
CZN	Iga, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	7
CZO	Inter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control	Class 1	21 CFR 866.5890
CZP	Iga, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	54
CZQ	Bence-Jones Protein, Antigen, Antiserum, Control	Class 2	21 CFR 866.5150	2
CZR	Hemopexin, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5490
CZS	Retinol-Binding Protein, Antigen, Antiserum, Control	Class 1	21 CFR 866.5765	3
CZT	Hemopexin, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5490
CZW	Complement C3, Antigen, Antiserum, Control	Class 2	21 CFR 866.5240	44
CZX	Hemopexin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5490	3
CZY	Complement C1s, Antigen, Antiserum, Control	Class 2	21 CFR 866.5240	1
CZZ	Haptoglobin, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5460
DAA	Igg, Peroxidase, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	5
DAB	Haptoglobin, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5460	3
DAC	Complement C3b Activator, Antigen, Antiserum, Control	Class 2	21 CFR 866.5260	2
DAD	Haptoglobin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5460	18
DAE	Complement C9, Antigen, Antiserum, Control	Class 2	21 CFR 866.5240	6
DAF	Gamma Globulin, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	1
DAG	Complement C8, Antigen, Antiserum, Control	Class 2	21 CFR 866.5240
DAH	Gamma Globulin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	7
DAI	Complement C1r, Antigen, Antiserum, Control	Class 2	21 CFR 866.5240
DAJ	Free Secretory Component, Antigen, Antiserum, Control	Class 2	21 CFR 866.5380
DAK	Complement C1q, Antigen, Antiserum, Control	Class 2	21 CFR 866.5240	28
DAL	Fraction Iv-5, Antigen, Antiserum, Control	Class 1	21 CFR 866.5360
DAM	Hemoglobin, Chain Specific, Antigen, Antiserum, Control	Class 2	21 CFR 866.5470
DAN	Fibrinopeptide A, Antigen, Antiserum, Control	Class 2	21 CFR 866.5350	3
DAO	Igm (Mu Chain Specific), Antigen, Antiserum, Control	Class 2	21 CFR 866.5550	8
DAQ	Igg (Fd Fragment Specific), Antigen, Antiserum, Control	Class 1	21 CFR 866.5540	1
DAS	Igg (Fc Fragment Specific), Antigen, Antiserum, Control	Class 1	21 CFR 866.5530	8
DAW	Alpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control	Class 1	21 CFR 866.5425
DAY	Complement C5, Antigen, Antiserum, Control	Class 2	21 CFR 866.5240	3
DBA	Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control	Class 2	21 CFR 866.5250	13
DBC	Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control	Class 1	21 CFR 866.5425
DBE	Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Contr	Class 2	21 CFR 866.5120	6
DBF	Ferritin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5340	87
DBH	Fc, Rhodamine, Antigen, Antiserum, Control	Class 1	21 CFR 866.5530
DBI	Complement C4, Antigen, Antiserum, Control	Class 2	21 CFR 866.5240	34
DBJ	Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control	Class 2	21 CFR 866.5110	2
DBK	Fc, Fitc, Antigen, Antiserum, Control	Class 1	21 CFR 866.5530
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	Class 2	21 CFR 866.5660	24
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Contr	Class 2	21 CFR 866.5090	27
DBN	Fc, Antigen, Antiserum, Control	Class 1	21 CFR 866.5530	1
DBT	Factor Xiii A, S, Antigen, Antiserum, Control	Class 1	21 CFR 866.5330	1
DBY	Fab, Rhodamine, Antigen, Antiserum, Control	Class 1	21 CFR 866.5520	6
DCB	Fab, Fitc, Antigen, Antiserum, Control	Class 1	21 CFR 866.5520	1
DCE	Fab, Antigen, Antiserum, Control	Class 1	21 CFR 866.5520	2
DCF	Albumin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5040	37
DCH	System, Test, C-Reactive Protein, Rhodamine	Class 2	21 CFR 866.5270	1
DCJ	Beta-Globulin, Antigen, Antiserum, Control	Class 1	21 CFR 866.5160	1
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Class 2	21 CFR 866.5270	126
DCN	System, Test, C-Reactive Protein	Class 2	21 CFR 866.5270	70
DCO	Alpha-Globulin, Antigen, Antiserum, Control	Class 1	21 CFR 866.5400
DCT	Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5210
DCY	Ceruloplasmin, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5210
DDB	Ceruloplasmin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5210	19
DDC	Thyroglobulin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5870	13
DDD	Transferrin, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5880	1
DDE	Carbonic Anhydrase C, Antigen, Antiserum, Control	Class 1	21 CFR 866.5200	3
DDF	Prothrombin, Antigen, Antiserum, Control	Class 1	21 CFR 866.5735	2
DDG	Transferrin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5880	48
DDH	Carbonic Anhydrase B, Antigen, Antiserum, Control	Class 1	21 CFR 866.5200
DDI	Transferrin, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5880	2
DDJ	Thyroglobulin, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5870
DDK	Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control	Class 1	21 CFR 866.5440
DDL	Thyroglobulin, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5870
DDN	Beta-2-Glycoprotein I, Antigen, Antiserum, Control	Class 1	21 CFR 866.5430
DDO	Myoglobin, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5680
DDR	Myoglobin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5680	46
DDS	Prealbumin, Fitc, Antigen, Antiserum, Control	Class 1	21 CFR 866.5060	4
DDT	Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5620
DDX	Plasminogen, Antigen, Antiserum, Control	Class 1	21 CFR 866.5715	10
DDY	Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5620	1
DDZ	Albumin, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5040	4
DEA	Myoglobin, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5680
DEB	Alpha-2-Macroglobulin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5620	13
DEC	Inter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control	Class 1	21 CFR 866.5890
DEF	Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control	Class 1	21 CFR 866.5425	1
DEG	Lactoferrin, Antigen, Antiserum, Control	Class 1	21 CFR 866.5570	8
DEH	Lambda, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550	53
DEI	Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5130	2
DEJ	Alpha-2-Glycoproteins, Antigen, Antiserum, Control	Class 1	21 CFR 866.5425
DEK	Kappa, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550
DEL	Lipoprotein X, Antigen, Antiserum, Control	Class 1	21 CFR 866.5590	5
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5130	30
DEN	Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control	Class 1	21 CFR 866.5420	2
DEO	Kappa, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550	2
DEP	Lambda, Peroxidase, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550	1
DER	Alpha-1-Lipoprotein, Antigen, Antiserum, Control	Class 2	21 CFR 866.5580	17
DES	Lambda, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550	2
DET	Lactic Dehydrogenase, Antigen, Antiserum, Control	Class 1	21 CFR 866.5560	1
DEW	Igg, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	76
DEX	Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control	Class 1	21 CFR 866.5420	5
DEY	Igm, Peroxidase, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550	3
DEZ	Igm, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550
DFB	Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5130	1
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Class 2	21 CFR 866.5600	43
DFD	Kappa, Peroxidase, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550	3
DFF	Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5080	1
DFG	Lambda, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550	1
DFH	Kappa, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550	63
DFI	Total Spinal-Fluid, Antigen, Antiserum, Control	Class 1	21 CFR 866.5860	4
DFJ	Albumin, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5040
DFK	Igg (Fab Fragment Specific), Antigen, Antiserum, Control	Class 1	21 CFR 866.5520	3
DFL	Igm, Ferritin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550	3
DFM	Ige, Ferritin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510
DFO	Igg, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510
DFQ	Sperm, Antigen, Antiserum, Control	Class 1	21 CFR 866.5800
DFS	Igm, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550	1
DFT	Igm, Antigen, Antiserum, Control	Class 2	21 CFR 866.5550	33
DFX	Sperm, Fitc, Antigen, Antiserum, Control	Class 1	21 CFR 866.5800
DFZ	Igg (Gamma Chain Specific), Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	9
DGA	Cohn Fraction Ii, Antigen, Antiserum, Control	Class 1	21 CFR 866.5220
DGB	Seminal Fluid, Antigen, Antiserum, Control	Class 1	21 CFR 866.5800	1
DGC	Ige, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	114
DGD	Igg, Ferritin, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	3
DGE	Igd, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	2
DGG	Igd, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510
DGH	Igd, Peroxidase, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	1
DGI	Breast Milk, Rhodamine, Antigen, Antiserum, Control	Class 1	21 CFR 866.5170
DGJ	Colostrum, Antigen, Antiserum, Control	Class 1	21 CFR 866.5230	1
DGK	Igg, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	2
DGL	Ige, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510
DGM	Breast Milk, Antigen, Antiserum, Control	Class 1	21 CFR 866.5170
DGN	Breast Milk, Fitc, Antigen, Antiserum, Control	Class 1	21 CFR 866.5170
DGO	Ige, Peroxidase, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	15
DGP	Ige, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 866.5510	4
DGQ	Whole Blood Plasma, Antigen, Antiserum, Control	Class 1	21 CFR 866.5700	1
DGR	Whole Human Serum, Antigen, Antiserum, Control	Class 1	21 CFR 866.5700	5
DGW	System, Test, Hypersensitivity Pneumonitis	Class 2	21 CFR 866.5500
DGX	Ng1m(A), Antigen, Antiserum, Control	Class 1	21 CFR 866.5065	1
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Class 2	21 CFR 866.5750	268
DHC	System, Test, Systemic Lupus Erythematosus	Class 2	21 CFR 866.5820	16
DHF	D/Km-1, Antigen, Antiserum, Control	Class 1	21 CFR 866.5065	1
DHI	Ng3m(Bo), Antigen, Antiserum, Control	Class 1	21 CFR 866.5065	1
DHL	Protein, Complement, Antigen, Antiserum, Control	Class 1	21 CFR 866.4100	4
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Class 2	21 CFR 866.5100	110
DHQ	Ng3m(G), Antigen, Antiserum, Control	Class 1	21 CFR 866.5065
DHR	System, Test, Rheumatoid Factor	Class 2	21 CFR 866.5775	144
DHX	System, Test, Carcinoembryonic Antigen	Class 2	21 CFR 866.6010	28
DHY	Ng4m(A), Antigen, Antiserum, Control	Class 1	21 CFR 866.5065	1
JFQ	P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin	Class 2	21 CFR 866.5210
JFR	Indirect Copper Assay, Ceruloplasmin	Class 2	21 CFR 866.5210	2
JHR	Radioimmunoassay, Immunoglobulins (D, E)	Class 2	21 CFR 866.5510	9
JKM	Immunochemical, Bence-Jones Protein	Class 2	21 CFR 866.5150	4
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Class 2	21 CFR 866.5340	24
JNL	Immunochemical, Thyroglobulin Autoantibody	Class 2	21 CFR 866.5870	22
JNM	Immunochemical, Transferrin	Class 2	21 CFR 866.5880	3
JZG	System, Test, Beta-2-Microglobulin Immunological	Class 2	21 CFR 866.5630	53
JZH	Factor B, Antigen, Antiserum, Control	Class 2	21 CFR 866.5320	6
JZJ	Prealbumin, Antigen, Antiserum, Control	Class 1	21 CFR 866.5060	11
JZO	System, Test, Thyroid Autoantibody	Class 2	21 CFR 866.5870	92
JZP	Plates, Ouchterlony Agar	Class 1	21 CFR 866.4600	1
JZQ	Plates And Equipment, Radial Immunodiffusion	Class 1	21 CFR 866.4800	7
JZR	Support Gels	Class 1	21 CFR 866.4900	2
JZS	Electrophoresis Instrumentation	Class 1	21 CFR 866.4500	6
JZT	Fluorometer	Class 1	21 CFR 866.4520	14
JZW	Nephelometer	Class 1	21 CFR 866.4540	11
JZX	Equipment, Rocket Immunoelectrophoresis	Class 1	21 CFR 866.4830	1
KHT	Fraction V, Antigen, Antiserum, Control	Class 1	21 CFR 866.5370	1
KTK	Reagent, Immunoassay, Carbonic Anhydrase B And C	Class 1	21 CFR 866.5200
KTL	Anti-Dna Indirect Immunofluorescent Solid Phase	Class 2	21 CFR 866.5100	19
KTM	C3-Indirect Immunofluorescent Solid Phase	Class 2	21 CFR 866.5240
KTN	System, Test, Infectious Mononucleosis	Class 2	21 CFR 866.5640	59
KTO	Reagent, Immunoassay, Igg	Class 1	21 CFR 866.5530	2
KTP	Complement C3b Activator Immunoassay Reagents	Class 2	21 CFR 866.5260	1
KTQ	Reagent, Complement	Class 1	21 CFR 866.4100	6
KTS	Second Antibody (Species Specific Anti-Animal Gamma Globulin)	Class 2	21 CFR 866.5510	4
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Class 2	21 CFR 866.5100	112
LKJ	Antinuclear Antibody, Antigen, Control	Class 2	21 CFR 866.5100	50
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Class 1	21 CFR 866.5420	11
LKO	Anti-Rnp Antibody, Antigen And Control	Class 2	21 CFR 866.5100	23
LKP	Anti-Sm Antibody, Antigen And Control	Class 2	21 CFR 866.5100	28
LLL	Extractable Antinuclear Antibody, Antigen And Control	Class 2	21 CFR 866.5100	182
LOJ	Kit, Test,Alpha-Fetoprotein For Testicular Cancer	Class 2	21 CFR 866.6010	17
LOQ	Device, General Purpose, Hematology	Class 2	21 CFR 866.6010	1
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Class 2	21 CFR 866.5100	29
LSW	Anti-Dna Antibody, Antigen And Control	Class 2	21 CFR 866.5100	8
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Class 2	21 CFR 866.6010	34
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Class 2	21 CFR 866.6010	26
LYE	Cytokeratins	Class 2	21 CFR 866.5550	2
MGA	Alpha-1 Microglobulin, Antigen, Antiserum, Control	Class 1	21 CFR 866.5400	2
MID	System, Test, Anticardiolipin Immunological	Class 2	21 CFR 866.5660	94
MLE	Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control	Class 2	21 CFR 866.5110	3
MLH	Strip, Hama Igg, Elisa, In Vitro Test System	Class 2	21 CFR 866.5510
MMW	System, Test, Tumor Marker, Monitoring, Bladder	Class 2	21 CFR 866.6010	9
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Class 2	21 CFR 866.5660	75
MOI	System, Test, Immunological, Antigen, Tumor	Class 2	21 CFR 866.6010	28
MQA	Anti-Ribosomal P Antibodies	Class 2	21 CFR 866.5100	4
MST	Antibodies, Gliadin	Class 2	21 CFR 866.5750	42
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Class 2	21 CFR 866.5660	46
MSW	System, Test, Thyroglobulin	Class 2	21 CFR 866.6010	13
MUT	Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Manage	Class 2	21 CFR 866.6010