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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 3 of 71
FDA product codes, page 3 of 71
CodeDevice nameClassRegulationClearancesRecalls
CFOTitrimetric, MagnesiumClass I21 CFR 862.149500
CFPRadioimmunoassay, Immunoreactive InsulinClass I21 CFR 862.1405278
CFQRadioimmunoassay, Immunoglobulins (G, A, M)Class II21 CFR 866.5510120
CFRHexokinase, GlucoseClass II21 CFR 862.134514522
CFTRadioimmunoassay, Prolactin (Lactogen)Class I21 CFR 862.1625806
CFWCopper Reduction, GlucoseClass II21 CFR 862.134500
CGAGlucose Oxidase, GlucoseClass II21 CFR 862.134540189
CGCRadioimmunoassay, GastrinClass I21 CFR 862.1325102
CGDFerricyanide, GlucoseClass II21 CFR 862.134500
CGEOrthotoluidine, GlucoseClass II21 CFR 862.1345120
CGFRadioimmunoassay, EstroneClass I21 CFR 862.128044
CGHElectrophoretic, GlobulinClass I21 CFR 862.133000
CGIRadioimmunoassay, EstriolClass I21 CFR 862.1265422
CGJRadioimmunoassay, Follicle-Stimulating HormoneClass I21 CFR 862.1300889
CGLElectrode, Ion Based, Enzymatic, CreatinineClass II21 CFR 862.122589
CGMMethod, Immunodiffusion, Immunoglobulins (G, A, M)Class II21 CFR 866.551040
CGNAcid, Folic, RadioimmunoassayClass II21 CFR 862.12956428
CGOLieberman-Burchard/Abell-Kendall, Colorimetric, CholesterolClass I21 CFR 862.1175110
CGRRadioimmunoassay, CortisolClass II21 CFR 862.1205847
CGSNad Reduction/Nadh Oxidation, Cpk Or IsoenzymesClass II21 CFR 862.121512310
CGTRadioimmunoassay, Cyclic GmpClass II21 CFR 862.123000
CGXAlkaline Picrate, Colorimetry, CreatinineClass II21 CFR 862.122515915
CGZElectrode, Ion-Specific, ChlorideClass II21 CFR 862.11703811
CHARadioimmunoassay, CorticosteroneClass I21 CFR 862.120000
CHCTitrimetric Permanganate And Bromophenol Blue, CalciumClass II21 CFR 862.114500
CHDAcid, Ferric Ion-Sulfuric, CholesterolClass I21 CFR 862.117530
CHERadioimmunoassay, CorticoidsClass I21 CFR 862.119500
CHGAcid, Phosphoric-Tungstic (Spectrophotometric), ChlorideClass II21 CFR 862.117030
CHHEnzymatic Esterase--Oxidase, CholesterolClass I21 CFR 862.117523023
CHILipase-Esterase, Enzymatic, Photometric, LipaseClass I21 CFR 862.14652022
CHJMercuric Thiocyanate, Colorimetry, ChlorideClass II21 CFR 862.1170530
CHKMercuric Nitrate And Diphenyl Carbazone (Titrimetric), ChlorideClass II21 CFR 862.117010
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClass II21 CFR 862.1120188184
CHMRadioimmunoassay, Total Estrogens In PregnancyClass I21 CFR 862.127001
CHNImmunochemical, CeruloplasminClass II21 CFR 866.521036
CHORadioimmunoassay, Cyclic AmpClass II21 CFR 862.123060
CHPRadioimmunoassay, EstradiolClass I21 CFR 862.12605031
CHQChromatographic/Fluorometric Method, CatecholaminesClass I21 CFR 862.1165100
CHRTitrimetric Phenol Red, Carbon-DioxideClass II21 CFR 862.116000
CHSCoulometric Method, Carbon-DioxideClass II21 CFR 862.116060
CHTElectrophoretic Method, CatecholaminesClass I21 CFR 862.116520
CHWTitrimetric With Edta And Indicator, CalciumClass II21 CFR 862.114530
CHZDi (O-Hydroxyphenylimine) Ethane, CalciumClass II21 CFR 862.114510
CIAMethylthymol Blue, CalciumClass II21 CFR 862.114550
CIBRadioimmunoassay, Angiotensin I And ReninClass II21 CFR 862.1085164
CICCresolphthalein Complexone, CalciumClass II21 CFR 862.11459910
CIDAlizarin Sulfonate, CalciumClass II21 CFR 862.114520
CIEVolumetric/Manometric, Carbon-DioxideClass II21 CFR 862.116070
CIFVanillin Pyruvate, Ast/SgotClass II21 CFR 862.110010
CIGDiazo Colorimetry, BilirubinClass II21 CFR 862.111023519
CIJSaccharogenic, AmylaseClass II21 CFR 862.1070311
CIKRadial Diffusion, AmylaseClass II21 CFR 862.107000
CILCresol Red Colorimetry, Carbon-DioxideClass II21 CFR 862.116040
CINElectrophoretic Separation, Alkaline Phosphatase IsoenzymesClass II21 CFR 862.1050267
CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or IsoenzymesClass II21 CFR 862.1050110
CIQDiazo, Ast/SgotClass II21 CFR 862.110071
CISHydrazone Colorimetry, Ast/SgotClass II21 CFR 862.110050
CITNadh Oxidation/Nad Reduction, Ast/SgotClass II21 CFR 862.110013913
CIWStarch-Dye Bound Polymer, AmylaseClass II21 CFR 862.107085
CIXBromcresol Green Dye-Binding, AlbuminClass II21 CFR 862.10351206
CIYRadioimmunoassay, AndrosteroneClass I21 CFR 862.108010
CIZRadioimmunoassay, AndrostenedioneClass I21 CFR 862.1075105
CJAAmyloclastic, AmylaseClass II21 CFR 862.1070100
CJBChromatographic Separation/Radioimmunoassay, AldosteroneClass II21 CFR 862.104500
CJCFructose-1, 6-Diphosphate And Nadh (U.V.), AldolaseClass I21 CFR 862.104000
CJDNitrosalicylate Reduction, AmylaseClass II21 CFR 862.107010
CJENitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesClass II21 CFR 862.105012422
CJFTetrabromophenolphthalein, AlbuminClass II21 CFR 862.103510
CJGTetrabromo-M-Cresolsulfonphthalein, AlbuminClass II21 CFR 862.103510
CJHThymol Blue Monophosphate, Alkaline Phosphatase Or IsoenzymesClass II21 CFR 862.105010
CJIDisodium Phenylphosphate, Alkaline Phosphatase Or IsoenzymesClass II21 CFR 862.105000
CJJDiazo, Alt/SgptClass I21 CFR 862.103020
CJKPhenolphthalein Phosphate, Alkaline Phosphatase Or IsoenzymesClass II21 CFR 862.105010
CJLBeta Glycerophosphate, Alkaline Phosphatase Or IsoenzymesClass II21 CFR 862.105010
CJMRadioimmunoassay, AldosteroneClass II21 CFR 862.1045120
CJNAcid Phosphatase, NitrophenylphosphateClass II21 CFR 862.102010
CJOAlpha-Naphthyl Phosphate, Alkaline Phosphatase Or IsoenzymesClass II21 CFR 862.105041
CJQRadial Immunodiffusion, AlbuminClass II21 CFR 862.103510
CJRAcid Phosphatase, Thymol Blue MonophosphateClass II21 CFR 862.102020
CJTHydrazone Colorimetry, AldolaseClass I21 CFR 862.104010
CJWBromcresol Purple Dye-Binding, AlbuminClass II21 CFR 862.1035181
CJXAcid Phosphatase, Disodium PhenylphosphateClass II21 CFR 862.102000
CJYAzo Dye, CalciumClass II21 CFR 862.11454710
CJZAcid, Hydroxyazobenzene-Benzoic, AlbuminClass II21 CFR 862.103500
CKANadh Oxidation/Nad Reduction, Alt/SgptClass I21 CFR 862.103012718
CKBAcid Phosphatase, Naphthyl PhosphateClass II21 CFR 862.1020242
CKCVanillin Pyruvate, Alt/SgptClass I21 CFR 862.103020
CKDHydrazone Colorimetry, Alt/SgptClass I21 CFR 862.1030112
CKEAcid Phosphatase, Thymolphthale InmonophosphateClass II21 CFR 862.102090
CKFPhenylphosphate, Alkaline Phosphatase Or IsoenzymesClass II21 CFR 862.105020
CKGRadioimmunoassay, ActhClass II21 CFR 862.1025306
CKHAcid Phosphatase, Beta GlycerophosphateClass II21 CFR 862.102001
CZJIgd, Antigen, Antiserum, ControlClass II21 CFR 866.551080
CZKIga, Rhodamine, Antigen, Antiserum, ControlClass II21 CFR 866.551010
CZLIga, Peroxidase, Antigen, Antiserum, ControlClass II21 CFR 866.551000
CZMIga, Ferritin, Antigen, Antiserum, ControlClass II21 CFR 866.551010
CZNIga, Fitc, Antigen, Antiserum, ControlClass II21 CFR 866.551070
CZOInter-Alpha Trypsin Inhibitor, Antigen, Antiserum, ControlClass I21 CFR 866.589000
CZPIga, Antigen, Antiserum, ControlClass II21 CFR 866.5510543
CZQBence-Jones Protein, Antigen, Antiserum, ControlClass II21 CFR 866.515020