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| Review panel | Panel code | Product codes |
|---|---|---|
| Anesthesiology | AN | 262 |
| Cardiovascular | CV | 437 |
| Clinical Chemistry | CH | 527 |
| Clinical Toxicology | TX | 338 |
| Dental | DE | 352 |
| Ear, Nose, Throat | EN | 269 |
| Gastroenterology, Urology | GU | 614 |
| General Hospital | HO | 394 |
| General, Plastic Surgery | SU | 562 |
| Hematology | HE | 281 |
| Immunology | IM | 278 |
| Medical Genetics | MG | 7 |
| Microbiology | MI | 554 |
| Neurology | NE | 291 |
| Obstetrics/Gynecology | OB | 269 |
| Ophthalmic | OP | 345 |
| Orthopedic | OR | 349 |
| Pathology | PA | 325 |
| Physical Medicine | PM | 210 |
| Radiology | RA | 216 |
| Code | Device name | Class | Regulation | Clearances | Recalls |
|---|---|---|---|---|---|
| GQF | Antiserum, Neutralization, Respiratory Syncytial Virus | Class I | 21 CFR 866.3480 | 0 | 0 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Class I | 21 CFR 866.3480 | 32 | 3 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | Class II | 21 CFR 866.3175 | 19 | 1 |
| GQI | Antiserum, Cf, Cytomegalovirus | Class II | 21 CFR 866.3175 | 18 | 0 |
| GQJ | Antiserum, Cf, Lymphocytic Choriomeningitis Virus | Class I | 21 CFR 866.3360 | 0 | 0 |
| GQK | Antigen, Cf, Lymphocytic Choriomeningitis Virus | Class I | 21 CFR 866.3360 | 0 | 0 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | Class II | 21 CFR 866.3305 | 37 | 0 |
| GQM | Antisera, Neutralization, Herpesvirus Hominis | Class II | 21 CFR 866.3305 | 3 | 0 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | Class II | 21 CFR 866.3305 | 34 | 0 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | Class II | 21 CFR 866.3305 | 16 | 1 |
| GQP | Antisera, Neutralization, Parainfluenza Virus 1-4 | Class I | 21 CFR 866.3400 | 2 | 0 |
| GQQ | Antisera, Hai, Parainfluenza Virus 1-4 | Class I | 21 CFR 866.3400 | 1 | 0 |
| GQR | Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4 | Class I | 21 CFR 866.3400 | 1 | 0 |
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | Class I | 21 CFR 866.3400 | 11 | 0 |
| GQT | Antisera, Cf, Parainfluenza Virus 1-4 | Class I | 21 CFR 866.3400 | 4 | 0 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | Class II | 21 CFR 866.3900 | 10 | 0 |
| GQX | Antiserum, Cf, Varicella-Zoster | Class II | 21 CFR 866.3900 | 11 | 2 |
| GQY | Antigen, Ha (Including Ha Control), Mumps Virus | Class I | 21 CFR 866.3380 | 0 | 0 |
| GQZ | Antiserum, Neutralization, Mumps Virus | Class I | 21 CFR 866.3380 | 0 | 0 |
| GRA | Antiserum, Fluorescent, Mumps Virus | Class I | 21 CFR 866.3380 | 3 | 0 |
| GRB | Antiserum, Cf, Mumps Virus | Class I | 21 CFR 866.3380 | 2 | 0 |
| GRC | Antigen, Cf (Including Cf Control), Mumps Virus | Class I | 21 CFR 866.3380 | 3 | 0 |
| GRD | Antiserum, Hai, Mumps Virus | Class I | 21 CFR 866.3380 | 1 | 0 |
| GRE | Antiserum, Fluorescent, Rubeola | Class I | 21 CFR 866.3520 | 4 | 0 |
| GRF | Antiserum, Cf, Rubeola | Class I | 21 CFR 866.3520 | 2 | 0 |
| GRG | Antiserum, Hai, Rubeola | Class I | 21 CFR 866.3520 | 0 | 0 |
| GRH | Antigen, Ha (Including Ha Control), Rubeola | Class I | 21 CFR 866.3520 | 0 | 0 |
| GRI | Antiserum, Neutralization, Rubeola | Class I | 21 CFR 866.3520 | 0 | 0 |
| GRJ | Antigen, Cf, (Including Cf Control), Rubeola | Class I | 21 CFR 866.3520 | 2 | 0 |
| GRK | Antisera, Fluorescent, Echovirus 1-34 | Class I | 21 CFR 866.3205 | 0 | 0 |
| GRL | Antigens, All Groups, Salmonella Spp. | Class II | 21 CFR 866.3550 | 2 | 0 |
| GRM | Antisera, All Groups, Salmonella Spp. | Class II | 21 CFR 866.3550 | 69 | 1 |
| GRO | Antisera, Fluorescent, All Types, Hemophilus Spp. | Class II | 21 CFR 866.3300 | 4 | 1 |
| GRP | Antisera, All Types, H. Influenza | Class II | 21 CFR 866.3300 | 6 | 1 |
| GRT | Antiserum, Fluorescent, Mycobacterium Tuberculosis | Class I | 21 CFR 866.3370 | 1 | 0 |
| GRW | Antisera, All Fluorescent, Leptospira Spp. | Class II | 21 CFR 866.3350 | 0 | 0 |
| GRX | Antisera, All Leptospira Spp. | Class II | 21 CFR 866.3350 | 0 | 0 |
| GRY | Antigens, All, Leptospira Spp. | Class II | 21 CFR 866.3350 | 2 | 0 |
| GRZ | Antisera, Fluorescent, All, Mycoplasma Spp. | Class I | 21 CFR 866.3375 | 5 | 0 |
| GSA | Antisera, All Mycoplasma Spp. | Class I | 21 CFR 866.3375 | 6 | 0 |
| GSB | Antigens, Cf, All, Mycoplasma Spp. | Class I | 21 CFR 866.3375 | 5 | 0 |
| GSD | Antiserum, Fluorescent, Erysipelothrix Rhusiopathiae | Class I | 21 CFR 866.3250 | 0 | 0 |
| GSE | Antiserum, Erysipelothrix Rhusiopathiae | Class I | 21 CFR 866.3250 | 0 | 0 |
| GSF | Antigen, Erysipelothrix Rhusiopathiae | Class I | 21 CFR 866.3250 | 0 | 0 |
| GSG | Antisera, Fluorescent, All Types, Listeria Monocytogenes | Class I | 21 CFR 866.3355 | 0 | 1 |
| GSH | Antisera, All Types, Listeria Monocytogenes | Class I | 21 CFR 866.3355 | 1 | 0 |
| GSI | Antigens, Slide And Tube, All Types, Listeria Monocytogenes | Class I | 21 CFR 866.3355 | 1 | 0 |
| GSJ | Antiserum, Fluorescent, Francisella Tularensis | Class II | 21 CFR 866.3280 | 1 | 0 |
| GSK | Antiserum, Francisella Tularensis | Class II | 21 CFR 866.3280 | 1 | 1 |
| GSL | Antigens, Slide And Tube, Francisella Tularensis | Class II | 21 CFR 866.3280 | 1 | 0 |
| GSM | Antisera, Fluorescent, Brucella Spp. | Class II | 21 CFR 866.3085 | 4 | 4 |
| GSN | Antiserum, Positive And Negative Febrile Antigen Control Serum | Class II | 21 CFR 866.3085 | 3 | 2 |
| GSO | Antigens (Febrile), Agglutination, Brucella Spp. | Class II | 21 CFR 866.3085 | 12 | 2 |
| GSP | Antiserum, Fluorescent, Campylobacter Fetus | Class I | 21 CFR 866.3110 | 0 | 0 |
| GSQ | Antiserum, Vibrio Cholerae, All Varieties | Class II | 21 CFR 866.3930 | 3 | 0 |
| GSR | Antisera, Fluorescent, Pseudomonas Pseudomallei | Class II | 21 CFR 866.3415 | 0 | 0 |
| GSS | Antisera, Fluorescent, Pseudomonas Aeruginosa | Class II | 21 CFR 866.3415 | 1 | 0 |
| GST | Antiserum, Pseudomonas Pseudomallei | Class II | 21 CFR 866.3415 | 0 | 0 |
| GSW | Antiserum, Flavobacterium Meningosepticum, All Groups | Class I | 21 CFR 866.3270 | 0 | 0 |
| GSX | Antisera, Acinetobacter Calcoaceticus, All Varieties | Class I | 21 CFR 866.3010 | 0 | 0 |
| GSY | Antisera, Fluorescent, All Globulins, Proteus Spp. | Class I | 21 CFR 866.3410 | 0 | 2 |
| GSZ | Antigens, Febrile (Weil-Felix), All Groups | Class I | 21 CFR 866.3410 | 3 | 0 |
| GTA | Antisera, All, Serratia Marcesans | Class I | 21 CFR 866.3630 | 0 | 0 |
| GTB | Antisera, Fluorescent, All Types, Klebsiella Spp. | Class I | 21 CFR 866.3340 | 0 | 0 |
| GTC | Antisera, All Types, Klebsiella Spp. | Class I | 21 CFR 866.3340 | 1 | 0 |
| GTD | Antisera, Fluorescent, All Globulins, Shigella Spp. | Class II | 21 CFR 866.3660 | 0 | 0 |
| GTE | Antisera, Arizona Spp., All | Class I | 21 CFR 866.3035 | 0 | 0 |
| GTF | Antisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp. | Class I | 21 CFR 866.3125 | 0 | 0 |
| GTH | Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae | Class II | 21 CFR 866.3390 | 3 | 0 |
| GTI | Antisera, Fluorescent, All Groups, N. Meningitidis | Class II | 21 CFR 866.3390 | 2 | 0 |
| GTJ | Antisera, All Groups, N. Meningitidis | Class II | 21 CFR 866.3390 | 16 | 5 |
| GTL | Phages, Staphylococcal Typing, All Types | Class I | 21 CFR 866.2050 | 0 | 0 |
| GTN | Antisera, Fluorescent, All Types, Staphylococcus Spp. | Class I | 21 CFR 866.3700 | 4 | 0 |
| GTO | Anti-Streptokinase | Class I | 21 CFR 866.3720 | 0 | 0 |
| GTP | Exoenzymes, Multiple, Streptococcal | Class I | 21 CFR 866.3720 | 3 | 0 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | Class I | 21 CFR 866.3720 | 37 | 4 |
| GTR | Antideoxyribonuclease, Streptococcus Spp. | Class I | 21 CFR 866.3720 | 1 | 0 |
| GTX | Antisera, Fluorescent, All Groups, Streptococcus Spp. | Class I | 21 CFR 866.3740 | 2 | 0 |
| GTY | Antigens, All Groups, Streptococcus Spp. | Class I | 21 CFR 866.3740 | 44 | 20 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | Class I | 21 CFR 866.3740 | 105 | 3 |
| GWB | Antisera, Fluorescent, All Types, Streptococcus Pneumoniae | Class I | 21 CFR 866.3740 | 2 | 0 |
| GWC | Antisera, All Types, Streptococcus Pneumoniae | Class I | 21 CFR 866.3740 | 9 | 0 |
| GWD | Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp | Class II | 21 CFR 866.3220 | 2 | 3 |
| GWE | Stimulator, Photic, Evoked Response | Class II | 21 CFR 882.1890 | 49 | 3 |
| GWF | Stimulator, Electrical, Evoked Response | Class II | 21 CFR 882.1870 | 141 | 16 |
| GWG | Endoscope, Neurological | Class II | 21 CFR 882.1480 | 93 | 22 |
| GWI | Discriminator, Two-Point | Class I | 21 CFR 882.1200 | 2 | 0 |
| GWJ | Stimulator, Auditory, Evoked Response | Class II | 21 CFR 882.1900 | 76 | 4 |
| GWK | Conditioner, Signal, Physiological | Class II | 21 CFR 882.1845 | 23 | 0 |
| GWL | Amplifier, Physiological Signal | Class II | 21 CFR 882.1835 | 53 | 4 |
| GWM | Device, Monitoring, Intracranial Pressure | Class II | 21 CFR 882.1620 | 105 | 52 |
| GWN | Nystagmograph | Class II | 21 CFR 882.1460 | 60 | 4 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | Class II | 21 CFR 882.5320 | 44 | 24 |
| GWQ | Full-Montage Standard Electroencephalograph | Class II | 21 CFR 882.1400 | 189 | 23 |
| GWR | Generator, Electroencephalograph Test Signal | Class I | 21 CFR 882.1430 | 0 | 0 |
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | Class I | 21 CFR 882.1420 | 15 | 0 |
| GWW | Ataxiagraph | Class I | 21 CFR 882.1030 | 0 | 0 |
| GWX | Fork, Tuning | Class I | 21 CFR 882.1525 | 4 | 0 |
| GWY | Pinwheel | Class I | 21 CFR 882.1750 | 5 | 0 |
| GWZ | Percussor | Class I | 21 CFR 882.1700 | 11 | 0 |
