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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 6 of 71
FDA product codes, page 6 of 71
CodeDevice nameClassRegulationClearancesRecalls
DKTFree Radical Assay, OpiatesClass II21 CFR 862.365000
DKWTest Reagents For Sulphanimide DerivativesClass I21 CFR 862.385000
DKXThin Layer Chromatography, BarbiturateClass II21 CFR 862.315020
DKYIndicator, Alumina Fluorescent, TlcClass I21 CFR 862.227000
DKZEnzyme Immunoassay, AmphetamineClass II21 CFR 862.310022524
DLATest Reagents For Methyl AlcoholClass II21 CFR 862.304000
DLBRadioimmunoassay, Lsd (125-I)Class II21 CFR 862.358070
DLCAtomizer, TlcClass I21 CFR 862.227000
DLDThin Layer Chromatography, CodeineClass II21 CFR 862.327000
DLEReagents, Test, BromidesClass II21 CFR 862.364500
DLFEnzyme Immunoassay, EthosuximideClass II21 CFR 862.338090
DLGCoating, Liquid, GlcClass I21 CFR 862.225070
DLHGas Chromatography, AlcoholClass II21 CFR 862.304000
DLIAcetylcholine Chloride, Specific Reagent For Pseudo CholinesteraseClass I21 CFR 862.324060
DLJCalibrators, Drug SpecificClass II21 CFR 862.32001235
DLNHemagglutination, Cocaine Metabolites (Benzoylecgnonine)Class II21 CFR 862.325040
DLOIndicator, Silica Gel Fluorescent, TlcClass I21 CFR 862.227000
DLPRadioimmunoassay, DiphenylhydantoinClass II21 CFR 862.335050
DLRHemagglutination Inhibition, MorphineClass II21 CFR 862.364020
DLSGas Chromatograph, Alcohol (Dedicated Instruments)Class II21 CFR 862.304000
DLTHemagglutination, OpiatesClass II21 CFR 862.365010
DLXHemagglutination Inhibition, BarbiturateClass II21 CFR 862.315000
DLYPlate, Alumina, TlcClass I21 CFR 862.227000
DLZEnzyme Immunoassay, PhenobarbitalClass II21 CFR 862.3660359
DMBGas Chromatography, MethadoneClass II21 CFR 862.362010
DMFGas Liquid Chromatography, BarbiturateClass II21 CFR 862.315000
DMGPapers, IonClass I21 CFR 862.223000
DMIPotassium Dichromate Specific Reagent For AlcoholClass II21 CFR 862.304010
DMJTest Reagents For Ethyl AlcoholClass II21 CFR 862.304000
DMKLead, Protoporphyrin, FluorometricClass II21 CFR 862.355000
DMLNad-Nadh, Specific Reagent For Alcohol Enzyme MethodClass II21 CFR 862.3040131
DMNThin Layer Chromatography, CocaineClass II21 CFR 862.325020
DMPDigoxin Control Serum, RiaClass I21 CFR 862.328040
DMQGas Chromatography, PrimidoneClass II21 CFR 862.368000
DMRSolution, M-Nitrophenol, Specific Reagent For CholinesteraseClass I21 CFR 862.324010
DMSGases, GlcClass I21 CFR 862.225000
DMTEnzymatic Method, Alcohol Dehydrogenase, UltravioletClass II21 CFR 862.304081
DMXLiquid Chromatography, SalicylateClass II21 CFR 862.383000
DMYGas Chromatography, MorphineClass II21 CFR 862.364010
DMZLiquid Chromatography, AdsorbentClass I21 CFR 862.226010
DNARadioimmunoassay, Morphine-Barbiturate (125-I), Goat AntibodyClass II21 CFR 862.364000
DNCStrip, Paper, SalicylateClass II21 CFR 862.383000
DNDRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.Class II21 CFR 862.330010
DNEAtomic Absorption, AntimonyClass I21 CFR 862.311000
DNFLiquid Chromatography, EthosuximideClass II21 CFR 862.338000
DNGFree Radical, BenzoylecgnonineClass II21 CFR 862.325000
DNHResins, Ion-Exchange, Liquid ChromatographyClass I21 CFR 862.226010
DNILiquid Chromatography, AmphetamineClass II21 CFR 862.310010
DNJRadioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.Class II21 CFR 862.332020
DNKThin Layer Chromatography, MorphineClass II21 CFR 862.364040
DNLRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.Class II21 CFR 862.332080
DNNCalibrators, Ethyl AlcoholClass II21 CFR 862.320072
DNOHemagglutination Inhibition, GentamicinClass II21 CFR 862.345010
DNPThin Layer Chromatography, EthosuximideClass II21 CFR 862.338010
DNQRadioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep.Class II21 CFR 862.332000
DNSRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep.Class II21 CFR 862.332000
DNTLiquid Chromatography, MethadoneClass II21 CFR 862.362000
DNWRadioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.Class II21 CFR 862.330000
DNXLead, Protoporphyrin Zinc Method, FluorometricClass II21 CFR 862.355000
DNZAtomic Absorption, ArsenicClass I21 CFR 862.312000
DOARadioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.Class II21 CFR 862.332011
DOBRadioimmunoassay, Digitoxin (3-H)Class II21 CFR 862.330000
DODGas Chromatography, AmphetamineClass II21 CFR 862.310010
DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.Class II21 CFR 862.3640120
DOFLead, Atomic AbsorptionClass II21 CFR 862.3550620
DOGRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene GlycolClass II21 CFR 862.332050
DOHElectrometry, CholinesteraseClass I21 CFR 862.324000
DOJPotassium Dichromate, AlcoholClass II21 CFR 862.304020
DOKFree Radical Assay, MorphineClass II21 CFR 862.364010
DOLFree Radical Assay, LsdClass II21 CFR 862.358000
DOMThin Layer Chromatography, BenzoylecgnonineClass II21 CFR 862.325000
DONRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.Class II21 CFR 862.3320170
DOOLiquid Chromatography, PhenobarbitalClass II21 CFR 862.366000
DOPMass Spectrometer, Clinical UseClass I21 CFR 862.28601016
DORRadioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.Class II21 CFR 862.332010
DOSThin Layer Chromatography, PrimidoneClass II21 CFR 862.368000
DOWRadioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated TubeClass II21 CFR 862.330000
DOXFluorometer, Lead (Dedicated Instruments)Class II21 CFR 862.355040
DOYRadioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.Class II21 CFR 862.332050
DOZLiquid Chromatography, DiphenylhydantoinClass II21 CFR 862.335010
DPAApparatus, General Use, Thin Layer ChromatographyClass I21 CFR 862.227050
DPBRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.Class II21 CFR 862.3320100
DPDRadioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.Class II21 CFR 862.332010
DPEThin Layer Chromatography, DiphenylhydantoinClass II21 CFR 862.335010
DPGRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.Class II21 CFR 862.330030
DPHMercury, Atomic AbsorptionClass I21 CFR 862.360020
DPIRadioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.Class II21 CFR 862.332000
DPJRadioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.Class II21 CFR 862.310020
DPKLiquid Chromatography, MorphineClass II21 CFR 862.364020
DPLRadioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep.Class II21 CFR 862.330000
DPMColumns, Liquid ChromatographyClass I21 CFR 862.2260160
DPNThin Layer Chromatography, PropoxypheneClass II21 CFR 862.370010
DPORadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.Class II21 CFR 862.3320140
DPPFree Radical Assay, MethadoneClass II21 CFR 862.362000
DPQLiquid Chromatography, PrimidoneClass II21 CFR 862.368000
DPSElectrocardiographClass II21 CFR 870.234057798
DPTProbe, Blood-Flow, ExtravascularClass II21 CFR 870.21204824
DPWFlowmeter, Blood, CardiovascularClass II21 CFR 870.210013835
DPZOximeter, EarClass II21 CFR 870.27101112
DQAOximeterClass II21 CFR 870.2700726128