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 |
|---|---|---|---|---|---|
| DFH | Kappa, Antigen, Antiserum, Control | Class II | 21 CFR 866.5550 | 63 | 2 |
| DFI | Total Spinal-Fluid, Antigen, Antiserum, Control | Class I | 21 CFR 866.5860 | 4 | 0 |
| DFJ | Albumin, Rhodamine, Antigen, Antiserum, Control | Class II | 21 CFR 866.5040 | 0 | 0 |
| DFK | Igg (Fab Fragment Specific), Antigen, Antiserum, Control | Class I | 21 CFR 866.5520 | 3 | 0 |
| DFL | Igm, Ferritin, Antigen, Antiserum, Control | Class II | 21 CFR 866.5550 | 3 | 0 |
| DFM | Ige, Ferritin, Antigen, Antiserum, Control | Class II | 21 CFR 866.5510 | 0 | 0 |
| DFO | Igg, Rhodamine, Antigen, Antiserum, Control | Class II | 21 CFR 866.5510 | 0 | 0 |
| DFQ | Sperm, Antigen, Antiserum, Control | Class I | 21 CFR 866.5800 | 0 | 1 |
| DFS | Igm, Fitc, Antigen, Antiserum, Control | Class II | 21 CFR 866.5550 | 1 | 0 |
| DFT | Igm, Antigen, Antiserum, Control | Class II | 21 CFR 866.5550 | 33 | 4 |
| DFX | Sperm, Fitc, Antigen, Antiserum, Control | Class I | 21 CFR 866.5800 | 0 | 0 |
| DFZ | Igg (Gamma Chain Specific), Antigen, Antiserum, Control | Class II | 21 CFR 866.5510 | 9 | 0 |
| DGA | Cohn Fraction Ii, Antigen, Antiserum, Control | Class I | 21 CFR 866.5220 | 0 | 0 |
| DGB | Seminal Fluid, Antigen, Antiserum, Control | Class I | 21 CFR 866.5800 | 1 | 0 |
| DGC | Ige, Antigen, Antiserum, Control | Class II | 21 CFR 866.5510 | 114 | 3 |
| DGD | Igg, Ferritin, Antigen, Antiserum, Control | Class II | 21 CFR 866.5510 | 3 | 0 |
| DGE | Igd, Rhodamine, Antigen, Antiserum, Control | Class II | 21 CFR 866.5510 | 2 | 0 |
| DGG | Igd, Fitc, Antigen, Antiserum, Control | Class II | 21 CFR 866.5510 | 0 | 0 |
| DGH | Igd, Peroxidase, Antigen, Antiserum, Control | Class II | 21 CFR 866.5510 | 1 | 0 |
| DGI | Breast Milk, Rhodamine, Antigen, Antiserum, Control | Class I | 21 CFR 866.5170 | 0 | 0 |
| DGJ | Colostrum, Antigen, Antiserum, Control | Class I | 21 CFR 866.5230 | 1 | 0 |
| DGK | Igg, Fitc, Antigen, Antiserum, Control | Class II | 21 CFR 866.5510 | 2 | 1 |
| DGL | Ige, Rhodamine, Antigen, Antiserum, Control | Class II | 21 CFR 866.5510 | 0 | 0 |
| DGM | Breast Milk, Antigen, Antiserum, Control | Class I | 21 CFR 866.5170 | 0 | 0 |
| DGN | Breast Milk, Fitc, Antigen, Antiserum, Control | Class I | 21 CFR 866.5170 | 0 | 0 |
| DGO | Ige, Peroxidase, Antigen, Antiserum, Control | Class II | 21 CFR 866.5510 | 15 | 0 |
| DGP | Ige, Fitc, Antigen, Antiserum, Control | Class II | 21 CFR 866.5510 | 4 | 0 |
| DGQ | Whole Blood Plasma, Antigen, Antiserum, Control | Class I | 21 CFR 866.5700 | 1 | 0 |
| DGR | Whole Human Serum, Antigen, Antiserum, Control | Class I | 21 CFR 866.5700 | 5 | 0 |
| DGW | System, Test, Hypersensitivity Pneumonitis | Class II | 21 CFR 866.5500 | 0 | 2 |
| DGX | Ng1m(A), Antigen, Antiserum, Control | Class I | 21 CFR 866.5065 | 1 | 0 |
| DHA | System, Test, Human Chorionic Gonadotropin | Class II | 21 CFR 862.1155 | 72 | 14 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | Class II | 21 CFR 866.5750 | 269 | 27 |
| DHC | System, Test, Systemic Lupus Erythematosus | Class II | 21 CFR 866.5820 | 16 | 1 |
| DHF | D/Km-1, Antigen, Antiserum, Control | Class I | 21 CFR 866.5065 | 1 | 0 |
| DHI | Ng3m(Bo), Antigen, Antiserum, Control | Class I | 21 CFR 866.5065 | 1 | 0 |
| DHL | Protein, Complement, Antigen, Antiserum, Control | Class I | 21 CFR 866.4100 | 4 | 0 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | Class II | 21 CFR 866.5100 | 110 | 7 |
| DHQ | Ng3m(G), Antigen, Antiserum, Control | Class I | 21 CFR 866.5065 | 0 | 0 |
| DHR | System, Test, Rheumatoid Factor | Class II | 21 CFR 866.5775 | 144 | 15 |
| DHX | System, Test, Carcinoembryonic Antigen | Class II | 21 CFR 866.6010 | 28 | 9 |
| DHY | Ng4m(A), Antigen, Antiserum, Control | Class I | 21 CFR 866.5065 | 1 | 0 |
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | Class II | 21 CFR 862.3040 | 33 | 6 |
| DID | Bacillus Subtilis Microbiology Assay, Tobramycin | Class II | 21 CFR 862.3900 | 5 | 0 |
| DIE | Heavy Metals Control Materials | Class I | 21 CFR 862.3280 | 5 | 0 |
| DIF | Drug Mixture Control Materials | Class I | 21 CFR 862.3280 | 202 | 10 |
| DIG | Cholinesterase Test Paper | Class I | 21 CFR 862.3240 | 1 | 0 |
| DIH | Colorimetry, Cholinesterase | Class I | 21 CFR 862.3240 | 26 | 5 |
| DII | Columns, Glc | Class I | 21 CFR 862.2250 | 5 | 0 |
| DIJ | Lead, Delta Amino Levulinic Acid | Class II | 21 CFR 862.3550 | 2 | 0 |
| DIK | Thin Layer Chromatography, Quinine | Class I | 21 CFR 862.3750 | 0 | 0 |
| DIL | Radioimmunoassay, Primidone | Class II | 21 CFR 862.3680 | 0 | 0 |
| DIM | Gas Chromatography, Salicylate | Class II | 21 CFR 862.3830 | 0 | 0 |
| DIN | Gas Chromatography, Cocaine | Class II | 21 CFR 862.3250 | 0 | 0 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class II | 21 CFR 862.3250 | 145 | 23 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | Class II | 21 CFR 862.3350 | 44 | 11 |
| DIQ | Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep. | Class II | 21 CFR 862.3640 | 0 | 0 |
| DIR | Free Radical Assay, Cocaine | Class II | 21 CFR 862.3250 | 1 | 0 |
| DIS | Enzyme Immunoassay, Barbiturate | Class II | 21 CFR 862.3150 | 100 | 7 |
| DIT | Thin Layer Chromatography, Amphetamine | Class II | 21 CFR 862.3100 | 4 | 0 |
| DIW | Hemagglutination Inhibition, Methadone | Class II | 21 CFR 862.3620 | 4 | 0 |
| DIX | Thin Layer Chromatography, Phenobarbital | Class II | 21 CFR 862.3660 | 0 | 0 |
| DIY | Gas Chromatography, Ethosuximide | Class II | 21 CFR 862.3380 | 1 | 0 |
| DIZ | Delayed Analysis, Alcohol | Class II | 21 CFR 862.3040 | 0 | 0 |
| DJA | Column Supports, Glc | Class I | 21 CFR 862.2250 | 1 | 0 |
| DJB | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. | Class II | 21 CFR 862.3450 | 19 | 0 |
| DJC | Thin Layer Chromatography, Methamphetamine | Class II | 21 CFR 862.3610 | 31 | 0 |
| DJD | Enzyme Immunoassay, Primidone | Class II | 21 CFR 862.3680 | 8 | 0 |
| DJE | Thin Layer Chromatography, Salicylate | Class II | 21 CFR 862.3830 | 1 | 0 |
| DJF | Gas Chromatography, Opiates | Class II | 21 CFR 862.3650 | 0 | 0 |
| DJG | Enzyme Immunoassay, Opiates | Class II | 21 CFR 862.3650 | 215 | 13 |
| DJH | Gas Chromatography, Phenobarbital | Class II | 21 CFR 862.3660 | 1 | 0 |
| DJI | Antiserum, Gentamicin | Class II | 21 CFR 862.3450 | 1 | 0 |
| DJJ | Fluorometry, Morphine | Class II | 21 CFR 862.3640 | 1 | 0 |
| DJK | Digitoxin Control Serum, Ria | Class I | 21 CFR 862.3280 | 1 | 0 |
| DJL | Free Radical Assay, Amphetamine | Class II | 21 CFR 862.3100 | 0 | 0 |
| DJN | Mercury Dithiazone, Colorimetry, Barbiturate | Class II | 21 CFR 862.3150 | 1 | 0 |
| DJO | Indicator, Cellulose Fluorescent, Tlc | Class I | 21 CFR 862.2270 | 0 | 0 |
| DJP | Radioimmunoassay, Amphetamine | Class II | 21 CFR 862.3100 | 9 | 0 |
| DJQ | Test Reagents For Phenothiazine | Class II | 21 CFR 862.3670 | 1 | 0 |
| DJR | Enzyme Immunoassay, Methadone | Class II | 21 CFR 862.3620 | 63 | 7 |
| DJS | U.V. Light, Tlc | Class I | 21 CFR 862.2270 | 1 | 0 |
| DJX | Radioimmunoassay, Ethosuximide | Class II | 21 CFR 862.3380 | 0 | 0 |
| DJY | Ion-Exchange Chromatography | Class I | 21 CFR 862.2230 | 11 | 0 |
| DJZ | Devices, Breath Trapping, Alcohol | Class I | 21 CFR 862.3050 | 28 | 3 |
| DKA | Antiserum, Digoxin | Class II | 21 CFR 862.3320 | 3 | 1 |
| DKB | Calibrators, Drug Mixture | Class II | 21 CFR 862.3200 | 94 | 9 |
| DKC | Alcohol Control Materials | Class I | 21 CFR 862.3280 | 11 | 5 |
| DKD | Bacillus Subtilis, Microbiological Assay, Gentamicin | Class II | 21 CFR 862.3450 | 2 | 0 |
| DKE | Reagents, Test, Tetrahydrocannabinol | Class II | 21 CFR 862.3870 | 12 | 0 |
| DKG | Plate, Cellulose, Tlc | Class I | 21 CFR 862.2270 | 1 | 0 |
| DKH | Gas Chromatography, Diphenylhydantoin | Class II | 21 CFR 862.3350 | 2 | 0 |
| DKJ | Colorimetry, Salicylate | Class II | 21 CFR 862.3830 | 29 | 6 |
| DKK | Tanks, Developing, Tlc | Class I | 21 CFR 862.2270 | 1 | 0 |
| DKN | Radioimmunoassay, Barbiturate | Class II | 21 CFR 862.3150 | 4 | 0 |
| DKO | Adsorbents, Ion-Exchange | Class I | 21 CFR 862.2230 | 1 | 0 |
| DKP | Radioimmunoassay, Phenobarbital | Class II | 21 CFR 862.3660 | 3 | 0 |
| DKQ | Antiserum, Digitoxin | Class II | 21 CFR 862.3300 | 0 | 0 |
| DKR | Thin Layer Chromatography, Methadone | Class II | 21 CFR 862.3620 | 0 | 0 |
| DKS | Plate, Silica Gel, Tlc | Class I | 21 CFR 862.2270 | 0 | 0 |
