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FDA product codes

The device classification tree, in product code order.

FDA classifies every device type under a three-letter product code, and that code is what ties a clearance to a recall to a registered listing. Each page here carries the FDA definition, the regulation it sits under, clearance volume by year, and the companies that list the code with FDA.

Data as of , the FDA export date. FDA product classification database

Review panels

6,880 codes
FDA review panels and the number of ingested product codes in each
Review panelPanel codeProduct codes
AnesthesiologyAN262
CardiovascularCV437
Clinical ChemistryCH527
Clinical ToxicologyTX338
DentalDE352
Ear, Nose, ThroatEN269
Gastroenterology, UrologyGU614
General HospitalHO394
General, Plastic SurgerySU562
HematologyHE281
ImmunologyIM278
Medical GeneticsMG7
MicrobiologyMI554
NeurologyNE291
Obstetrics/GynecologyOB269
OphthalmicOP345
OrthopedicOR349
PathologyPA325
Physical MedicinePM210
RadiologyRA216

214 codes carry no review panel in the FDA classification file and appear only in the index below

7,094 product codes, page 5 of 71
FDA product codes, page 5 of 71
CodeDevice nameClassRegulationClearancesRecalls
DFHKappa, Antigen, Antiserum, ControlClass II21 CFR 866.5550632
DFITotal Spinal-Fluid, Antigen, Antiserum, ControlClass I21 CFR 866.586040
DFJAlbumin, Rhodamine, Antigen, Antiserum, ControlClass II21 CFR 866.504000
DFKIgg (Fab Fragment Specific), Antigen, Antiserum, ControlClass I21 CFR 866.552030
DFLIgm, Ferritin, Antigen, Antiserum, ControlClass II21 CFR 866.555030
DFMIge, Ferritin, Antigen, Antiserum, ControlClass II21 CFR 866.551000
DFOIgg, Rhodamine, Antigen, Antiserum, ControlClass II21 CFR 866.551000
DFQSperm, Antigen, Antiserum, ControlClass I21 CFR 866.580001
DFSIgm, Fitc, Antigen, Antiserum, ControlClass II21 CFR 866.555010
DFTIgm, Antigen, Antiserum, ControlClass II21 CFR 866.5550334
DFXSperm, Fitc, Antigen, Antiserum, ControlClass I21 CFR 866.580000
DFZIgg (Gamma Chain Specific), Antigen, Antiserum, ControlClass II21 CFR 866.551090
DGACohn Fraction Ii, Antigen, Antiserum, ControlClass I21 CFR 866.522000
DGBSeminal Fluid, Antigen, Antiserum, ControlClass I21 CFR 866.580010
DGCIge, Antigen, Antiserum, ControlClass II21 CFR 866.55101143
DGDIgg, Ferritin, Antigen, Antiserum, ControlClass II21 CFR 866.551030
DGEIgd, Rhodamine, Antigen, Antiserum, ControlClass II21 CFR 866.551020
DGGIgd, Fitc, Antigen, Antiserum, ControlClass II21 CFR 866.551000
DGHIgd, Peroxidase, Antigen, Antiserum, ControlClass II21 CFR 866.551010
DGIBreast Milk, Rhodamine, Antigen, Antiserum, ControlClass I21 CFR 866.517000
DGJColostrum, Antigen, Antiserum, ControlClass I21 CFR 866.523010
DGKIgg, Fitc, Antigen, Antiserum, ControlClass II21 CFR 866.551021
DGLIge, Rhodamine, Antigen, Antiserum, ControlClass II21 CFR 866.551000
DGMBreast Milk, Antigen, Antiserum, ControlClass I21 CFR 866.517000
DGNBreast Milk, Fitc, Antigen, Antiserum, ControlClass I21 CFR 866.517000
DGOIge, Peroxidase, Antigen, Antiserum, ControlClass II21 CFR 866.5510150
DGPIge, Fitc, Antigen, Antiserum, ControlClass II21 CFR 866.551040
DGQWhole Blood Plasma, Antigen, Antiserum, ControlClass I21 CFR 866.570010
DGRWhole Human Serum, Antigen, Antiserum, ControlClass I21 CFR 866.570050
DGWSystem, Test, Hypersensitivity PneumonitisClass II21 CFR 866.550002
DGXNg1m(A), Antigen, Antiserum, ControlClass I21 CFR 866.506510
DHASystem, Test, Human Chorionic GonadotropinClass II21 CFR 862.11557214
DHBSystem, Test, Radioallergosorbent (Rast) ImmunologicalClass II21 CFR 866.575026927
DHCSystem, Test, Systemic Lupus ErythematosusClass II21 CFR 866.5820161
DHFD/Km-1, Antigen, Antiserum, ControlClass I21 CFR 866.506510
DHINg3m(Bo), Antigen, Antiserum, ControlClass I21 CFR 866.506510
DHLProtein, Complement, Antigen, Antiserum, ControlClass I21 CFR 866.410040
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, ControlClass II21 CFR 866.51001107
DHQNg3m(G), Antigen, Antiserum, ControlClass I21 CFR 866.506500
DHRSystem, Test, Rheumatoid FactorClass II21 CFR 866.577514415
DHXSystem, Test, Carcinoembryonic AntigenClass II21 CFR 866.6010289
DHYNg4m(A), Antigen, Antiserum, ControlClass I21 CFR 866.506510
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodClass II21 CFR 862.3040336
DIDBacillus Subtilis Microbiology Assay, TobramycinClass II21 CFR 862.390050
DIEHeavy Metals Control MaterialsClass I21 CFR 862.328050
DIFDrug Mixture Control MaterialsClass I21 CFR 862.328020210
DIGCholinesterase Test PaperClass I21 CFR 862.324010
DIHColorimetry, CholinesteraseClass I21 CFR 862.3240265
DIIColumns, GlcClass I21 CFR 862.225050
DIJLead, Delta Amino Levulinic AcidClass II21 CFR 862.355020
DIKThin Layer Chromatography, QuinineClass I21 CFR 862.375000
DILRadioimmunoassay, PrimidoneClass II21 CFR 862.368000
DIMGas Chromatography, SalicylateClass II21 CFR 862.383000
DINGas Chromatography, CocaineClass II21 CFR 862.325000
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClass II21 CFR 862.325014523
DIPEnzyme Immunoassay, DiphenylhydantoinClass II21 CFR 862.33504411
DIQRadioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.Class II21 CFR 862.364000
DIRFree Radical Assay, CocaineClass II21 CFR 862.325010
DISEnzyme Immunoassay, BarbiturateClass II21 CFR 862.31501007
DITThin Layer Chromatography, AmphetamineClass II21 CFR 862.310040
DIWHemagglutination Inhibition, MethadoneClass II21 CFR 862.362040
DIXThin Layer Chromatography, PhenobarbitalClass II21 CFR 862.366000
DIYGas Chromatography, EthosuximideClass II21 CFR 862.338010
DIZDelayed Analysis, AlcoholClass II21 CFR 862.304000
DJAColumn Supports, GlcClass I21 CFR 862.225010
DJBRadioimmunoassay, Gentamicin (125-I), Second Antibody Sep.Class II21 CFR 862.3450190
DJCThin Layer Chromatography, MethamphetamineClass II21 CFR 862.3610310
DJDEnzyme Immunoassay, PrimidoneClass II21 CFR 862.368080
DJEThin Layer Chromatography, SalicylateClass II21 CFR 862.383010
DJFGas Chromatography, OpiatesClass II21 CFR 862.365000
DJGEnzyme Immunoassay, OpiatesClass II21 CFR 862.365021513
DJHGas Chromatography, PhenobarbitalClass II21 CFR 862.366010
DJIAntiserum, GentamicinClass II21 CFR 862.345010
DJJFluorometry, MorphineClass II21 CFR 862.364010
DJKDigitoxin Control Serum, RiaClass I21 CFR 862.328010
DJLFree Radical Assay, AmphetamineClass II21 CFR 862.310000
DJNMercury Dithiazone, Colorimetry, BarbiturateClass II21 CFR 862.315010
DJOIndicator, Cellulose Fluorescent, TlcClass I21 CFR 862.227000
DJPRadioimmunoassay, AmphetamineClass II21 CFR 862.310090
DJQTest Reagents For PhenothiazineClass II21 CFR 862.367010
DJREnzyme Immunoassay, MethadoneClass II21 CFR 862.3620637
DJSU.V. Light, TlcClass I21 CFR 862.227010
DJXRadioimmunoassay, EthosuximideClass II21 CFR 862.338000
DJYIon-Exchange ChromatographyClass I21 CFR 862.2230110
DJZDevices, Breath Trapping, AlcoholClass I21 CFR 862.3050283
DKAAntiserum, DigoxinClass II21 CFR 862.332031
DKBCalibrators, Drug MixtureClass II21 CFR 862.3200949
DKCAlcohol Control MaterialsClass I21 CFR 862.3280115
DKDBacillus Subtilis, Microbiological Assay, GentamicinClass II21 CFR 862.345020
DKEReagents, Test, TetrahydrocannabinolClass II21 CFR 862.3870120
DKGPlate, Cellulose, TlcClass I21 CFR 862.227010
DKHGas Chromatography, DiphenylhydantoinClass II21 CFR 862.335020
DKJColorimetry, SalicylateClass II21 CFR 862.3830296
DKKTanks, Developing, TlcClass I21 CFR 862.227010
DKNRadioimmunoassay, BarbiturateClass II21 CFR 862.315040
DKOAdsorbents, Ion-ExchangeClass I21 CFR 862.223010
DKPRadioimmunoassay, PhenobarbitalClass II21 CFR 862.366030
DKQAntiserum, DigitoxinClass II21 CFR 862.330000
DKRThin Layer Chromatography, MethadoneClass II21 CFR 862.362000
DKSPlate, Silica Gel, TlcClass I21 CFR 862.227000