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 2026-10-05, 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 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

214 codes carry no review panel in the FDA classification file and appear only in the index below

7,094 product codes, page 17 of 71

FDA product codes, page 17 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
GKZ	Counter, Differential Cell	Class II	21 CFR 864.5220	381	244
GLE	Mixer, Blood Tube	Class I	21 CFR 862.2050	5	0
GLG	Platelet Counting, Manual	Class I	21 CFR 864.6160	3	0
GLK	Control, Hematocrit	Class II	21 CFR 864.8625	7	0
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Class II	21 CFR 864.8625	10	0
GLY	Oximeter To Measure Hemoglobin	Class II	21 CFR 864.7500	5	0
GLZ	Antigens, If, Toxoplasma Gondii	Class II	21 CFR 866.3780	18	0
GMA	Antisera, Fluorescent, Sporothrix Schenekii	Class I	21 CFR 866.3680	1	0
GMB	Light, Wood'S, Fluorescence	Class I	21 CFR 866.2600	0	0
GMD	Antisera, Latex Agglutination, Cryptococcus Neoformans	Class II	21 CFR 866.3165	10	3
GME	Antisera, Fluorescent, Cryptococcus Neoformans	Class II	21 CFR 866.3165	0	0
GMG	Antigen, Latex Agglutination, Coccidioides Immitis	Class II	21 CFR 866.3135	5	0
GMH	Antiserum, Positive Control, Coccidioides Immitis	Class II	21 CFR 866.3135	5	0
GMI	Antigen, Cf And / Or Id, Coccidioides Immitis	Class II	21 CFR 866.3135	11	1
GMJ	Antigens, Histoplasma Capsulatum, All	Class II	21 CFR 866.3320	12	2
GMK	Antiserum, Positive Control, Histoplasma Capsulatum	Class II	21 CFR 866.3320	9	0
GML	Antisera, Fluorescent, Histoplasma Capsulatum	Class II	21 CFR 866.3320	0	0
GMM	Antigens, Iha, Toxoplasma Gondii	Class II	21 CFR 866.3780	8	0
GMN	Antigens, Cf, Toxoplasma Gondii	Class II	21 CFR 866.3780	3	0
GMO	Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.	Class II	21 CFR 866.3220	0	0
GMP	Antisera, Control For Nontreponemal Tests	Class II	21 CFR 866.3820	9	0
GMQ	Antigens, Nontreponemal, All	Class II	21 CFR 866.3820	32	0
GMR	Sera, Reactive And Non-Specific Control, Fta-Abs Test	Class II	21 CFR 866.3830	0	0
GMS	Anti-Human Globulin, Fta-Abs Test	Class II	21 CFR 866.3830	3	0
GMT	Antigens, Ha, Treponema Pallidum	Class II	21 CFR 866.3830	9	0
GMW	Test, Sorbent, Fta-Abs	Class II	21 CFR 866.3830	0	2
GMX	Antisera, Fluorescent Antibody For Fta-Abs Test	Class II	21 CFR 866.3830	0	0
GMY	Antisera, Fluorescent, All Types, Escherichia Coli	Class I	21 CFR 866.3255	2	0
GMZ	Antigens, All Types, Escherichia Coli	Class I	21 CFR 866.3255	14	2
GNA	Antisera, All Types, Escherichia Coli	Class I	21 CFR 866.3255	12	1
GNB	Antisera, All Types, Shigella Spp.	Class II	21 CFR 866.3660	41	3
GNC	Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.	Class II	21 CFR 866.3550	60	5
GND	Antigen, Iha, T. Cruzi	Class I	21 CFR 866.3870	0	0
GNE	Antigen, Latex Agglutination, T. Cruzi	Class I	21 CFR 866.3870	1	0
GNF	Antigen, Cf, T. Cruzi	Class I	21 CFR 866.3870	0	0
GNG	Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6	Class I	21 CFR 866.3145	2	0
GNH	Antigen, Fluorescent Antibody Test, Schistosoma Mansoni	Class I	21 CFR 866.3600	2	0
GNI	Antisera, Neutralization, Echovirus 1-34	Class I	21 CFR 866.3205	0	0
GNJ	Antigens, Ha, Echovirus 1-34	Class I	21 CFR 866.3205	1	0
GNK	Antisera, Cf, Echovirus 1-34	Class I	21 CFR 866.3205	3	0
GNL	Antigens, Cf (Including Cf Control), Echovirus 1-34	Class I	21 CFR 866.3205	2	0
GNM	Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6	Class I	21 CFR 866.3145	9	0
GNN	Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6	Class I	21 CFR 866.3145	1	0
GNO	Antisera, Cf, Coxsackievirus A 1-24, B 1-6	Class I	21 CFR 866.3145	1	0
GNP	Antiserum, Cf, Epstein-Barr Virus	Class I	21 CFR 866.3235	20	2
GNQ	Antigen, Cf (Including Cf Control), Epstein-Barr Virus	Class I	21 CFR 866.3235	0	0
GNR	Antisera, Neutralization, Influenza Virus A, B, C	Class I	21 CFR 866.3330	1	0
GNS	Antisera, Hai, Influenza Virus A, B, C	Class I	21 CFR 866.3330	9	0
GNT	Antigens, Ha (Including Ha Control), Influenza Virus A, B, C	Class I	21 CFR 866.3330	5	0
GNW	Antisera, Cf, Influenza Virus A, B, C	Class I	21 CFR 866.3330	16	2
GNX	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	Class I	21 CFR 866.3330	18	10
GNY	Antisera, Fluorescent, Adenovirus 1-33	Class I	21 CFR 866.3020	4	0
GNZ	Antisera, Neutralization, Adenovirus 1-33	Class I	21 CFR 866.3020	0	0
GOA	Antisera, Cf, Adenovirus 1-33	Class I	21 CFR 866.3020	1	0
GOB	Antigens, Ha (Including Ha Control), Adenovirus 1-33	Class I	21 CFR 866.3020	1	0
GOC	Antisera, Hai, Adenovirus 1-33	Class I	21 CFR 866.3020	0	0
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Class I	21 CFR 866.3020	11	1
GOE	Antisera, Fluorescent, Poliovirus 1-3	Class I	21 CFR 866.3405	7	0
GOF	Antisera, Neutralization, Poliovirus 1-3	Class I	21 CFR 866.3405	0	0
GOG	Antisera, Cf, Poliovirus 1-3	Class I	21 CFR 866.3405	3	0
GOH	Antigens, Cf (Including Cf Control), Poliovirus 1-3	Class I	21 CFR 866.3405	0	0
GOI	Antiserum, Fluorescent, Rabies Virus	Class II	21 CFR 866.3460	2	0
GOJ	Antisera, Neutralization, Rubella	Class II	21 CFR 866.3510	0	0
GOK	Antisera, Hai (Including Hai Control), Rubella	Class II	21 CFR 866.3510	11	0
GOL	Antigen, Ha (Including Ha Control), Rubella	Class II	21 CFR 866.3510	21	0
GOM	Antisera, Cf, Rubella	Class II	21 CFR 866.3510	2	0
GON	Antigen, Cf (Including Cf Control), Rubella	Class II	21 CFR 866.3510	5	0
GOO	Antisera, Fluorescent, All Globulins, Salmonella Spp.	Class II	21 CFR 866.3550	0	0
GOP	Antisera, C. Acnes (553, 605)	Class I	21 CFR 866.3140	0	0
GOS	Antiserum, Fluorescent, C. Diphtheriae	Class I	21 CFR 866.3140	0	0
GOT	Antigen, B. Parapertussis	Class I	21 CFR 866.3065	0	0
GOW	Antisera, Agglutinating, B. Parapertussis	Class I	21 CFR 866.3065	0	0
GOX	Antigen, B. Pertussis	Class I	21 CFR 866.3065	1	0
GOY	Antisera, Agglutinating, B. Pertussis, All	Class I	21 CFR 866.3065	1	1
GOZ	Antisera, Fluorescent, B. Pertussis	Class I	21 CFR 866.3065	0	0
GPD	Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus	Class I	21 CFR 866.3200	0	0
GPE	Antisera, Positive Control, Echinococcus Spp.	Class I	21 CFR 866.3200	0	0
GPF	Antigen, Agglutinating, Echinococcus Spp.	Class I	21 CFR 866.3200	1	0
GPG	Antigen, Latex Agglutination, Trichinella Spiralis	Class I	21 CFR 866.3850	2	0
GPH	Antiserum, Bentonite Flocculation, Trichinella Spiralis	Class I	21 CFR 866.3850	0	0
GPI	Antigen, Bentonite Flocculation, Trichinella Spiralis	Class I	21 CFR 866.3850	0	0
GPJ	Antiserum, Fluorescent, Q Fever	Class I	21 CFR 866.3500	2	0
GPK	Antiserum, Rickettsial Pox	Class I	21 CFR 866.3500	0	0
GPM	Antiserum, Murine Typhus Fever	Class I	21 CFR 866.3500	1	0
GPN	Antiserum, Typhus Fever	Class I	21 CFR 866.3500	1	1
GPO	Antigen, Cf, Typhus Fever Group	Class I	21 CFR 866.3500	1	0
GPP	Antiserum, Rocky Mountain Spotted Fever	Class I	21 CFR 866.3500	1	0
GPQ	Antigen, Cf, Spotted Fever Group	Class I	21 CFR 866.3500	0	0
GPR	Antiserum, Cf, Q Fever	Class I	21 CFR 866.3500	0	0
GPS	Antigen, Cf, Q Fever	Class I	21 CFR 866.3500	1	0
GPT	Antiserum, Cf, Psittacosis (Chlamydia Group)	Class I	21 CFR 866.3120	1	0
GPW	Antigen, Cf, Psittacosis (Chlamydia Group)	Class I	21 CFR 866.3120	4	0
GPX	Antisera, Neutralizion, Reovirus 1-3	Class I	21 CFR 866.3470	0	0
GPY	Antisera, Hai, Reovirus 1-3	Class I	21 CFR 866.3470	0	0
GPZ	Antisera, Cf, Reovirus 1-3	Class I	21 CFR 866.3470	0	0
GQA	Antigens, Ha (Including Ha Control), Reovirus 1-3	Class I	21 CFR 866.3470	0	0
GQB	Antigens, Cf (Including Cf Control), Reovirus 1-3	Class I	21 CFR 866.3470	0	0
GQC	Antisera, Cf, Equine Encephalitis Virus, Eee, Wee	Class I	21 CFR 866.3240	2	0
GQD	Antigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee	Class I	21 CFR 866.3240	0	0
GQE	Antisera, Neutralization, All Types, Rhinovirus	Class I	21 CFR 866.3490	0	0