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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 18 of 71
FDA product codes, page 18 of 71
CodeDevice nameClassRegulationClearancesRecalls
GQFAntiserum, Neutralization, Respiratory Syncytial VirusClass I21 CFR 866.348000
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial VirusClass I21 CFR 866.3480323
GQHAntigen, Cf (Including Cf Control), CytomegalovirusClass II21 CFR 866.3175191
GQIAntiserum, Cf, CytomegalovirusClass II21 CFR 866.3175180
GQJAntiserum, Cf, Lymphocytic Choriomeningitis VirusClass I21 CFR 866.336000
GQKAntigen, Cf, Lymphocytic Choriomeningitis VirusClass I21 CFR 866.336000
GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2Class II21 CFR 866.3305370
GQMAntisera, Neutralization, Herpesvirus HominisClass II21 CFR 866.330530
GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2Class II21 CFR 866.3305340
GQOAntisera, Cf, Herpesvirus Hominis 1,2Class II21 CFR 866.3305161
GQPAntisera, Neutralization, Parainfluenza Virus 1-4Class I21 CFR 866.340020
GQQAntisera, Hai, Parainfluenza Virus 1-4Class I21 CFR 866.340010
GQRAntigens, Ha (Including Ha Control), Parainfluenza Virus 1-4Class I21 CFR 866.340010
GQSAntigens, Cf (Including Cf Control), Parainfluenza Virus 1-4Class I21 CFR 866.3400110
GQTAntisera, Cf, Parainfluenza Virus 1-4Class I21 CFR 866.340040
GQWAntigen, Cf, (Including Cf Control), Varicella-ZosterClass II21 CFR 866.3900100
GQXAntiserum, Cf, Varicella-ZosterClass II21 CFR 866.3900112
GQYAntigen, Ha (Including Ha Control), Mumps VirusClass I21 CFR 866.338000
GQZAntiserum, Neutralization, Mumps VirusClass I21 CFR 866.338000
GRAAntiserum, Fluorescent, Mumps VirusClass I21 CFR 866.338030
GRBAntiserum, Cf, Mumps VirusClass I21 CFR 866.338020
GRCAntigen, Cf (Including Cf Control), Mumps VirusClass I21 CFR 866.338030
GRDAntiserum, Hai, Mumps VirusClass I21 CFR 866.338010
GREAntiserum, Fluorescent, RubeolaClass I21 CFR 866.352040
GRFAntiserum, Cf, RubeolaClass I21 CFR 866.352020
GRGAntiserum, Hai, RubeolaClass I21 CFR 866.352000
GRHAntigen, Ha (Including Ha Control), RubeolaClass I21 CFR 866.352000
GRIAntiserum, Neutralization, RubeolaClass I21 CFR 866.352000
GRJAntigen, Cf, (Including Cf Control), RubeolaClass I21 CFR 866.352020
GRKAntisera, Fluorescent, Echovirus 1-34Class I21 CFR 866.320500
GRLAntigens, All Groups, Salmonella Spp.Class II21 CFR 866.355020
GRMAntisera, All Groups, Salmonella Spp.Class II21 CFR 866.3550691
GROAntisera, Fluorescent, All Types, Hemophilus Spp.Class II21 CFR 866.330041
GRPAntisera, All Types, H. InfluenzaClass II21 CFR 866.330061
GRTAntiserum, Fluorescent, Mycobacterium TuberculosisClass I21 CFR 866.337010
GRWAntisera, All Fluorescent, Leptospira Spp.Class II21 CFR 866.335000
GRXAntisera, All Leptospira Spp.Class II21 CFR 866.335000
GRYAntigens, All, Leptospira Spp.Class II21 CFR 866.335020
GRZAntisera, Fluorescent, All, Mycoplasma Spp.Class I21 CFR 866.337550
GSAAntisera, All Mycoplasma Spp.Class I21 CFR 866.337560
GSBAntigens, Cf, All, Mycoplasma Spp.Class I21 CFR 866.337550
GSDAntiserum, Fluorescent, Erysipelothrix RhusiopathiaeClass I21 CFR 866.325000
GSEAntiserum, Erysipelothrix RhusiopathiaeClass I21 CFR 866.325000
GSFAntigen, Erysipelothrix RhusiopathiaeClass I21 CFR 866.325000
GSGAntisera, Fluorescent, All Types, Listeria MonocytogenesClass I21 CFR 866.335501
GSHAntisera, All Types, Listeria MonocytogenesClass I21 CFR 866.335510
GSIAntigens, Slide And Tube, All Types, Listeria MonocytogenesClass I21 CFR 866.335510
GSJAntiserum, Fluorescent, Francisella TularensisClass II21 CFR 866.328010
GSKAntiserum, Francisella TularensisClass II21 CFR 866.328011
GSLAntigens, Slide And Tube, Francisella TularensisClass II21 CFR 866.328010
GSMAntisera, Fluorescent, Brucella Spp.Class II21 CFR 866.308544
GSNAntiserum, Positive And Negative Febrile Antigen Control SerumClass II21 CFR 866.308532
GSOAntigens (Febrile), Agglutination, Brucella Spp.Class II21 CFR 866.3085122
GSPAntiserum, Fluorescent, Campylobacter FetusClass I21 CFR 866.311000
GSQAntiserum, Vibrio Cholerae, All VarietiesClass II21 CFR 866.393030
GSRAntisera, Fluorescent, Pseudomonas PseudomalleiClass II21 CFR 866.341500
GSSAntisera, Fluorescent, Pseudomonas AeruginosaClass II21 CFR 866.341510
GSTAntiserum, Pseudomonas PseudomalleiClass II21 CFR 866.341500
GSWAntiserum, Flavobacterium Meningosepticum, All GroupsClass I21 CFR 866.327000
GSXAntisera, Acinetobacter Calcoaceticus, All VarietiesClass I21 CFR 866.301000
GSYAntisera, Fluorescent, All Globulins, Proteus Spp.Class I21 CFR 866.341002
GSZAntigens, Febrile (Weil-Felix), All GroupsClass I21 CFR 866.341030
GTAAntisera, All, Serratia MarcesansClass I21 CFR 866.363000
GTBAntisera, Fluorescent, All Types, Klebsiella Spp.Class I21 CFR 866.334000
GTCAntisera, All Types, Klebsiella Spp.Class I21 CFR 866.334010
GTDAntisera, Fluorescent, All Globulins, Shigella Spp.Class II21 CFR 866.366000
GTEAntisera, Arizona Spp., AllClass I21 CFR 866.303500
GTFAntisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.Class I21 CFR 866.312500
GTHAntiserum, Fluorescent (Direct Test), All Groups, N. GonorrhoeaeClass II21 CFR 866.339030
GTIAntisera, Fluorescent, All Groups, N. MeningitidisClass II21 CFR 866.339020
GTJAntisera, All Groups, N. MeningitidisClass II21 CFR 866.3390165
GTLPhages, Staphylococcal Typing, All TypesClass I21 CFR 866.205000
GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.Class I21 CFR 866.370040
GTOAnti-StreptokinaseClass I21 CFR 866.372000
GTPExoenzymes, Multiple, StreptococcalClass I21 CFR 866.372030
GTQAntistreptolysin - Titer/Streptolysin O ReagentClass I21 CFR 866.3720374
GTRAntideoxyribonuclease, Streptococcus Spp.Class I21 CFR 866.372010
GTXAntisera, Fluorescent, All Groups, Streptococcus Spp.Class I21 CFR 866.374020
GTYAntigens, All Groups, Streptococcus Spp.Class I21 CFR 866.37404420
GTZAntisera, All Groups, Streptococcus Spp.Class I21 CFR 866.37401053
GWBAntisera, Fluorescent, All Types, Streptococcus PneumoniaeClass I21 CFR 866.374020
GWCAntisera, All Types, Streptococcus PneumoniaeClass I21 CFR 866.374090
GWDIndirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel SpClass II21 CFR 866.322023
GWEStimulator, Photic, Evoked ResponseClass II21 CFR 882.1890493
GWFStimulator, Electrical, Evoked ResponseClass II21 CFR 882.187014116
GWGEndoscope, NeurologicalClass II21 CFR 882.14809322
GWIDiscriminator, Two-PointClass I21 CFR 882.120020
GWJStimulator, Auditory, Evoked ResponseClass II21 CFR 882.1900764
GWKConditioner, Signal, PhysiologicalClass II21 CFR 882.1845230
GWLAmplifier, Physiological SignalClass II21 CFR 882.1835534
GWMDevice, Monitoring, Intracranial PressureClass II21 CFR 882.162010552
GWNNystagmographClass II21 CFR 882.1460604
GWOPlate, Cranioplasty, Preformed, AlterableClass II21 CFR 882.53204424
GWQFull-Montage Standard ElectroencephalographClass II21 CFR 882.140018923
GWRGenerator, Electroencephalograph Test SignalClass I21 CFR 882.143000
GWSAnalyzer, Spectrum, Electroencephalogram SignalClass I21 CFR 882.1420150
GWWAtaxiagraphClass I21 CFR 882.103000
GWXFork, TuningClass I21 CFR 882.152540
GWYPinwheelClass I21 CFR 882.175050
GWZPercussorClass I21 CFR 882.1700110