Part 866 Subpart F—Immunological Test Systems

FDA submissions for Part 866 Subpart F—Immunological Test Systems in the Immunology (IM) review panel, including product codes and regulations.

Section range: §§ 866.5040–866.5970

CFR Part: 866

Product Codes

Product CodeDevice NameRegulationClassDevices
DCFAlbumin, Antigen, Antiserum, Control866.5040237
DDZAlbumin, Fitc, Antigen, Antiserum, Control866.504024
DFJAlbumin, Rhodamine, Antigen, Antiserum, Control866.504020
DDSPrealbumin, Fitc, Antigen, Antiserum, Control866.506014
JZJPrealbumin, Antigen, Antiserum, Control866.5060111
DGXNg1m(A), Antigen, Antiserum, Control866.506511
DHFD/Km-1, Antigen, Antiserum, Control866.506511
DHINg3m(Bo), Antigen, Antiserum, Control866.506511
DHQNg3m(G), Antigen, Antiserum, Control866.506510
DHYNg4m(A), Antigen, Antiserum, Control866.506511
DFFAlpha-1-Antichymotrypsin, Antigen, Antiserum, Control866.508021
DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control866.5090227
NRIAutoantibodies, Nuclear Pore Glycoprotein Gp210866.509022
NUMAutoantibodies, Nuclear Body Protein, Sp100866.509021
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control866.51002110
KTLAnti-Dna Indirect Immunofluorescent Solid Phase866.5100219
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls866.51002112
LKJAntinuclear Antibody, Antigen, Control866.5100250
LKOAnti-Rnp Antibody, Antigen And Control866.5100223
LKPAnti-Sm Antibody, Antigen And Control866.5100228
LLLExtractable Antinuclear Antibody, Antigen And Control866.51002180
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control866.5100229
LSWAnti-Dna Antibody, Antigen And Control866.510028
MQAAnti-Ribosomal P Antibodies866.510024
NYOAutoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody866.510024
OBEAnti-Ss-A 52 Autoantibodies866.510022
PETAnti-Ss-A Ro60 Autoantibodies866.510020
DBJAntiparietal Antibody, Indirect Immunofluorescent, Antigen, Control866.511022
MLEEnzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control866.511023
DBEAntismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control866.512026
NJFAntibodies, Anti-Actin, Anti-Smooth Muscle866.512021
DEIAlpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control866.513022
DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control866.5130230
DFBAlpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control866.513021
OBZAlpha-1-Antitrypsin Kit, Qualitative Phenotype866.513022
PZHSerpina1 Variant Detection System866.513023
CZQBence-Jones Protein, Antigen, Antiserum, Control866.515022
JKMImmunochemical, Bence-Jones Protein866.515024
DCJBeta-Globulin, Antigen, Antiserum, Control866.516011
DGIBreast Milk, Rhodamine, Antigen, Antiserum, Control866.517010
DGMBreast Milk, Antigen, Antiserum, Control866.517010
DGNBreast Milk, Fitc, Antigen, Antiserum, Control866.517010
NXOCalprotectin, Fecal866.5180215
DDECarbonic Anhydrase C, Antigen, Antiserum, Control866.520013
DDHCarbonic Anhydrase B, Antigen, Antiserum, Control866.520010
KTKReagent, Immunoassay, Carbonic Anhydrase B And C866.520010
CHNImmunochemical, Ceruloplasmin866.521023
DCTCeruloplasmin, Rhodamine, Antigen, Antiserum, Control866.521020
DCYCeruloplasmin, Fitc, Antigen, Antiserum, Control866.521020
DDBCeruloplasmin, Antigen, Antiserum, Control866.5210219
JFQP-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin866.521020
JFRIndirect Copper Assay, Ceruloplasmin866.521022
DGACohn Fraction Ii, Antigen, Antiserum, Control866.522010
DGJColostrum, Antigen, Antiserum, Control866.523011
CZWComplement C3, Antigen, Antiserum, Control866.5240244
CZYComplement C1s, Antigen, Antiserum, Control866.524021
DAEComplement C9, Antigen, Antiserum, Control866.524026
DAGComplement C8, Antigen, Antiserum, Control866.524020
DAIComplement C1r, Antigen, Antiserum, Control866.524020
DAKComplement C1q, Antigen, Antiserum, Control866.5240228
DAYComplement C5, Antigen, Antiserum, Control866.524023
DBIComplement C4, Antigen, Antiserum, Control866.5240234
KTMC3-Indirect Immunofluorescent Solid Phase866.524020
DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control866.5250213
DACComplement C3b Activator, Antigen, Antiserum, Control866.526022
KTPComplement C3b Activator Immunoassay Reagents866.526021
DCHSystem, Test, C-Reactive Protein, Rhodamine866.527021
DCKC-Reactive Protein, Antigen, Antiserum, And Control866.52702126
DCNSystem, Test, C-Reactive Protein866.5270270
NQDCardiac C-Reactive Protein, Antigen, Antiserum, And Control866.5270219
JZHFactor B, Antigen, Antiserum, Control866.532026
DBTFactor Xiii A, S, Antigen, Antiserum, Control866.533011
DBFFerritin, Antigen, Antiserum, Control866.5340287
JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin866.5340224
DANFibrinopeptide A, Antigen, Antiserum, Control866.535023
DALFraction Iv-5, Antigen, Antiserum, Control866.536010
KHTFraction V, Antigen, Antiserum, Control866.537011
DAJFree Secretory Component, Antigen, Antiserum, Control866.538020
DCOAlpha-Globulin, Antigen, Antiserum, Control866.540010
MGAAlpha-1 Microglobulin, Antigen, Antiserum, Control866.540012
DENAlpha-1-T-Glycoprotein, Antigen, Antiserum, Control866.542012
DEXAlpha-1-B-Glycoprotein, Antigen, Antiserum, Control866.542015
LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control866.5420111
DAWAlpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control866.542510
DBCAlpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control866.542510
DEFAlpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control866.542511
DEJAlpha-2-Glycoproteins, Antigen, Antiserum, Control866.542510
DDNBeta-2-Glycoprotein I, Antigen, Antiserum, Control866.543010
DDKBeta-2-Glycoprotein Iii, Antigen, Antiserum, Control866.544010
CZZHaptoglobin, Rhodamine, Antigen, Antiserum, Control866.546020
DABHaptoglobin, Fitc, Antigen, Antiserum, Control866.546023
DADHaptoglobin, Antigen, Antiserum, Control866.5460218
DAMHemoglobin, Chain Specific, Antigen, Antiserum, Control866.547020
CZRHemopexin, Rhodamine, Antigen, Antiserum, Control866.549020
CZTHemopexin, Fitc, Antigen, Antiserum, Control866.549020
CZXHemopexin, Antigen, Antiserum, Control866.549023
DGWSystem, Test, Hypersensitivity Pneumonitis866.550020
CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)866.5510229
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)866.5510261
CFQRadioimmunoassay, Immunoglobulins (G, A, M)866.5510212
CGMMethod, Immunodiffusion, Immunoglobulins (G, A, M)866.551024
CZJIgd, Antigen, Antiserum, Control866.551028
CZKIga, Rhodamine, Antigen, Antiserum, Control866.551021
CZLIga, Peroxidase, Antigen, Antiserum, Control866.551020
CZMIga, Ferritin, Antigen, Antiserum, Control866.551021
CZNIga, Fitc, Antigen, Antiserum, Control866.551027
CZPIga, Antigen, Antiserum, Control866.5510254
DAAIgg, Peroxidase, Antigen, Antiserum, Control866.551025
DAFGamma Globulin, Fitc, Antigen, Antiserum, Control866.551021
DAHGamma Globulin, Antigen, Antiserum, Control866.551027
DEWIgg, Antigen, Antiserum, Control866.5510276
DFMIge, Ferritin, Antigen, Antiserum, Control866.551020
DFOIgg, Rhodamine, Antigen, Antiserum, Control866.551020
DFZIgg (Gamma Chain Specific), Antigen, Antiserum, Control866.551029
DGCIge, Antigen, Antiserum, Control866.55102114
DGDIgg, Ferritin, Antigen, Antiserum, Control866.551023
DGEIgd, Rhodamine, Antigen, Antiserum, Control866.551022
DGGIgd, Fitc, Antigen, Antiserum, Control866.551020
DGHIgd, Peroxidase, Antigen, Antiserum, Control866.551021
DGKIgg, Fitc, Antigen, Antiserum, Control866.551022
DGLIge, Rhodamine, Antigen, Antiserum, Control866.551020
DGOIge, Peroxidase, Antigen, Antiserum, Control866.5510215
DGPIge, Fitc, Antigen, Antiserum, Control866.551024
JHRRadioimmunoassay, Immunoglobulins (D, E)866.551029
KTSSecond Antibody (Species Specific Anti-Animal Gamma Globulin)866.551024
MLHStrip, Hama Igg, Elisa, In Vitro Test System866.551020
OPXImmunoglobulin A Kappa Heavy & Light Chain Combined866.551023
OPYIgal Heavy & Light Chain Combined866.551020
PCNImmunoglobulin G Kappa Heavy And Light Chain Combined866.551023
PCOImmunoglobulin G Lambda Heavy And Light Chain Combined866.551020
PDEImmunoglobulin M Kappa Heavy And Light Chain Combined866.551022
PDFImmunoglobulin M Lambda Heavy And Light Chain Combined866.551020
SGGMass Spectrometric, Immunoglobulins (G, A, M, D, E)866.551021
DBYFab, Rhodamine, Antigen, Antiserum, Control866.552016
DCBFab, Fitc, Antigen, Antiserum, Control866.552011
DCEFab, Antigen, Antiserum, Control866.552012
DFKIgg (Fab Fragment Specific), Antigen, Antiserum, Control866.552013
DASIgg (Fc Fragment Specific), Antigen, Antiserum, Control866.553018
DBHFc, Rhodamine, Antigen, Antiserum, Control866.553010
DBKFc, Fitc, Antigen, Antiserum, Control866.553010
DBNFc, Antigen, Antiserum, Control866.553011
KTOReagent, Immunoassay, Igg866.553012
DAQIgg (Fd Fragment Specific), Antigen, Antiserum, Control866.554011
DAOIgm (Mu Chain Specific), Antigen, Antiserum, Control866.555028
DEHLambda, Antigen, Antiserum, Control866.5550253
DEKKappa, Rhodamine, Antigen, Antiserum, Control866.555020
DEOKappa, Fitc, Antigen, Antiserum, Control866.555022
DEPLambda, Peroxidase, Antigen, Antiserum, Control866.555021
DESLambda, Fitc, Antigen, Antiserum, Control866.555022
DEYIgm, Peroxidase, Antigen, Antiserum, Control866.555023
DEZIgm, Rhodamine, Antigen, Antiserum, Control866.555020
DFDKappa, Peroxidase, Antigen, Antiserum, Control866.555023
DFGLambda, Rhodamine, Antigen, Antiserum, Control866.555021
DFHKappa, Antigen, Antiserum, Control866.5550263
DFLIgm, Ferritin, Antigen, Antiserum, Control866.555023
DFSIgm, Fitc, Antigen, Antiserum, Control866.555021
DFTIgm, Antigen, Antiserum, Control866.5550233
LYECytokeratins866.555022
DETLactic Dehydrogenase, Antigen, Antiserum, Control866.556011
DEGLactoferrin, Antigen, Antiserum, Control866.557018
DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control866.5580217
DELLipoprotein X, Antigen, Antiserum, Control866.559015
DFCLipoprotein, Low-Density, Antigen, Antiserum, Control866.5600242
NOETest, System, Immunoassay, Lipoprotein-Associated Phospholipase A2866.560028
NTVMyeloperoxidase, Immunoassay, System, Test866.560022
DDTAlpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control866.562020
DDYAlpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control866.562021
DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control866.5620213
JZGSystem, Test, Beta-2-Microglobulin Immunological866.5630253
KTNSystem, Test, Infectious Mononucleosis866.5640259
DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control866.5660224
MIDSystem, Test, Anticardiolipin Immunological866.5660294
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)866.5660274
MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)866.5660246
MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)866.566026
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)866.5660240
MVSKit, Typing, Hla-Dqb866.566021
NBOAutoantibodies, Skin (Desmoglein 1 And Desmoglein 3)866.566022
NBSAutoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)866.566023
NIYAutoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis866.566023
NSTAutoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking866.566024
NWGAutoantibodies, Glutamic Acid Decarboxylase (Gad)866.566022
OCNInsulin Autoantibody Kit866.566021
OEGAutoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230866.566023
OIFTyrosine Phosphatase (Ia-2) Autoantibody Assay866.566023
OPNAuto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex866.566021
OSKAnti-Glutamate Receptor (Type Nmda) Ifa866.566021
PAFVoltage Gated Calcium Channel (Vgcc) Antibody Assay866.566021
PCG21-Hydroxylase Antibody (21-Ohab)866.566022
PNIAquaporin-4 Autoantibody866.566522
PHFZinc Transporter 8 Auto-Antibody866.567021
DDOMyoglobin, Rhodamine, Antigen, Antiserum, Control866.568020
DDRMyoglobin, Antigen, Antiserum, Control866.5680246
DEAMyoglobin, Fitc, Antigen, Antiserum, Control866.568020
MVEBiosensor, Immunoassay, Myoglobin866.568021
DGQWhole Blood Plasma, Antigen, Antiserum, Control866.570011
DGRWhole Human Serum, Antigen, Antiserum, Control866.570015
DDXPlasminogen, Antigen, Antiserum, Control866.5715110
DDFProthrombin, Antigen, Antiserum, Control866.573512
DHBSystem, Test, Radioallergosorbent (Rast) Immunological866.57502264
MSTAntibodies, Gliadin866.5750242
PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens866.575020
OYLTryptase Assay System866.576022
CZSRetinol-Binding Protein, Antigen, Antiserum, Control866.576513
DHRSystem, Test, Rheumatoid Factor866.57752144
NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)866.5775221
NPHAntigen, Cartilage Oligomeric Matrix Protein (Comp)866.577520
OQZAnti-Mutated Citrullinated Vimentin Igg866.577521
NBTAntibodies, Saccharomyces Cerevisiae (S.Cerevisiae)866.578528
OKMAntibodies, Outer-Membrane Proteins866.578521
DFQSperm, Antigen, Antiserum, Control866.580010
DFXSperm, Fitc, Antigen, Antiserum, Control866.580010
DGBSeminal Fluid, Antigen, Antiserum, Control866.580011
DHCSystem, Test, Systemic Lupus Erythematosus866.5820216
NRXComplement 4d (C4d) And Complement Receptor 1 (Cr1)866.582020
QATBrain Trauma Assessment Test866.583026
QSEAlzheimer’S Disease Pathology Assessment Test866.584023
SETImmunoassay Blood Test For Amyloid Pathology Assessment866.584022
SFCNeurologic Disease Risk Assessment Molecular Test866.585021
DFITotal Spinal-Fluid, Antigen, Antiserum, Control866.586014
DDCThyroglobulin, Antigen, Antiserum, Control866.5870213
DDJThyroglobulin, Fitc, Antigen, Antiserum, Control866.587020
DDLThyroglobulin, Rhodamine, Antigen, Antiserum, Control866.587020
JNLImmunochemical, Thyroglobulin Autoantibody866.5870222
JZOSystem, Test, Thyroid Autoantibody866.5870292
DDDTransferrin, Rhodamine, Antigen, Antiserum, Control866.588021
DDGTransferrin, Antigen, Antiserum, Control866.5880248
DDITransferrin, Fitc, Antigen, Antiserum, Control866.588022
JNMImmunochemical, Transferrin866.588023
CZOInter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control866.589010
DECInter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control866.589010
NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection866.5900212
PFRSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection866.590021
PFSSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection866.590021
PFXSystem, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection866.592022
PJISevere Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System866.593022
PKBAutosomal Recessive Carrier Screening Gene Mutation Detection System866.594021
PTAGenetic Variant Detection And Health Risk Assessment System866.595025
QUKHuman Leukocyte Antigen (Hla) Typing Companion Diagnostic Test866.596020
OYVInherited Nucleotide Repeat Disorder Dna Test866.597021
Innolitics

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