Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032839

FEI Number

3004185580

Entity Name

EPITOPE DIAGNOSTICS, INC.

City/State/Country

SAN DIEGO, CA, US

Establishment Address

17034 Camino San Bernardo, SAN DIEGO, CA 92127, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EPITOPE DIAGNOSTICS, INC. (Owner Number: 9059077)

Owner / Operator Contact Address

17034 Camino San Bernardo, --, San Diego, CA 92127, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CL0010 EDIAnti-Infliximab CLIA Kit CL0009 EDIInfliximab CLIA Kit CL010 ECL25 Cuvettes CL011 ECL100 Cuvettes CL0011 EDI Fecal Lactoferrin CLIA Kit KT-806 Human Anti-Human Antibody (HAHA) ELISA Kit KT-805 Human Anti-Mouse Antibody (HAMA) ELISA Kit KT-807 MAHA ELISA Kit SKT-015 Human Thyroid Stimulating Hormone CLIA Kit KT-918 EpiTuub Fecal Adenovirus Antigen Rapid Test Kit KT-842 Fecal Adenovirus Antigen ELISA Kit CL0012 EDI Fecal Secretory IgA CLIA Kit KT 898 Serolisa Human Anti-Zika Virus IgM ELISA Kit KT 897 Serolisa Human Anti-Zika Virus IgG ELISA Kit ECL25 ECL100 QSE180 Autosampler KT-935 EpiTuub® Fecal C. difficile Antigen Test Kit KT-835 Fecal C.difficile Toxin B ELISA Kit KT-828 Fecal C. difficile GDH ELISA Kit KT-834 Fecal C.difficile Toxin A ELISA Kit KT-836 Fecal C.difficile Toxin A & B ELISA Kit CL0827 Fecal Clostridium Difficile Toxin A CLIA Kit CL0828 Fecal Clostridium Difficile Toxin B CLIA Kit CL0824 Fecal Clostridium Difficile GDH Antigen CLIA Kit CL0836 Fecal Clostridium Difficile Toxin A & B CLIA Kit SKT-071 Human cardiac troponin I CLIA Kit SKT-050 Human High-Sensitivity Cardiac Troponin T CLIA Kit KT-929 EpiTuub Fecal H. pylori Antigen Rapid Test Kit KT-1015 Helicobacter Pylori IgG ELISA Kit KT-826 Fecal Helicobacter Pylori Antigen ELISA Kit KT-113 eCasset Helicobacter pylori Antigen Rapid Test Kit CL0826 Fecal Helicobacter pylori Antigen CLIA Kit KT-824 Fecal H.pylori Antigen ELISA Kit KT-812 Human Chromogranin A ELISA Kit CL0820 Human Chromogranin A CLIA Kit KT-820 Human Chromogranin A ELISA Kit KT-855 Human Chromogranin A ELISA Kit KT 1034 COVID-19 Nucleocapsid IgG Quantitative ELISA Kit KT 1033 Novel Coronavirus COVID-19 IgM ELISA Kit KT 1036 Quantitative SARS-CoV-2 Neutralizing Antibody ELISA Kit KT 1032 Novel Coronavirus COVID-19 IgG ELISA Kit KT 1035 Quantitative SARS-CoV-2 Spike Protein IgG ELISA Kit KT 882 EDI Human ACTH ELISA Kit KT 879 EDI Human Intact FGF-21 ELISA Kit KT 876 EDI Total GLP-1 ELISA Kit KT 871 EDI Active GLP-1 (7-36) Specific ELISA Kit KT 878 EDI Rodent Active GLP-1 (7-36) Specific ELISA Kit KTR 873 Serolisa Human nFGF-21 ELISA Kit KTR 866 Serolisa Human ncFGF-21 ELISA Kit KT 800 EDI Human Fetuin-A ELISA Kit KT 602 EDI Human Total GLP-1 ELISA Kit KTR 874 Serolisa Human cFGF-21 ELISA Kit KT-809 Human Osteocalcin (1-43/49) Specific ELISA Kit CL0809 Human Osteocalcin (1-43/49) Specific CLIA Kit FPC300 Fecal Ova/Parasite Concentration Kit FPC200 Fecal Ova/Parasite Concentration Kit SKT-031 Human N-terminal pro brain natriuretic peptide CLIA Kit CL0817 EDI 17-OH-Progesterone CLIA Kit SKT-045 Human Gastrin-17 CLIA Kit CL0015 EDI Anti-Adalimumab CLIA Kit CL0014 EDI Adalimumab CLIA Kit SKT-022 Human Progesterone CLIA Kit SKT-016 Human Follicle-stimulating Hormone CLIA Kit KT-920 EpiTuub Calprotectin Rapid Test Kit KT-112 eCasset Calprotectin Rapid Test Kit KT-921 EpiTuub Calprotectin Rapid Test Kit KT-849 Quantitative Fecal Calprotectin ELISA Kit CL0849 Human Calprotectin CLIA Kit SKT-026 Human Alpha Fetoprotein CLIA Kit SKT-042 Human Growth Hormone CLIA Kit KT 819 EDI Human Growth Hormone ELISA Kit EDI CL0004 Tissue Transglutaminase IgG CLIA Kit CL0005 Tissue Transglutaminase IgA CLIA Kit SKT-040 Total Triiodothyronine CLIA Kit SKT-038 Free Triiodothyronine CLIA Kit SKT-025 Human Procalcitonin CLIA Kit CL0013 EDI Glial Fibrillary Acidic Protein CLIA kit SKT-056 Cancer Antigen 15-3 (CA15-3) CLIA Kit KT-716 EDI Vitamin B12 ELISA Kit SKT-070 Human Vitamin B12 CLIA Kit EDI KT-880 Quantitative Fecal/Urine Myeloperoxidase ELISA Kit KT-890 Quantitative Serum/Plasma Myeloperoxidase ELISA Kit SKT-033 Human Epididymal protein 4 (HE4) CLIA Kit SKT-057 Cancer Antigen 19-9 (CA19-9) CLIA Kit SKT-043 Human Ferritin CLIA Kit KT 886 EDI Human Insulin ELISA Kit SKT-048 Human Insulin CLIA Kit KT 887 EDI Human Ultra Sensitive Insulin ELISA Kit SKT-020 Human Testosterone CLIA Kit SKT-029 Human Carcinoembryonic Antigen CLIA Kit SKT-035 Cancer Antigen 125 (CA-125) CLIA Kit KT-854 Fecal Sample Collection Kit KT-843 Calprotectin Sample Collection Kit KT-848 Stool Sampler Kit 31315 Stool Sampler 30210 Fecal Sample Collection Kit SKT-024 Human Creatine kinase-MB CLIA Kit SKT-051 Human Myoglobin CLIA Kit KT-868 Hepatitis A Virus IgM ELISA Kit KT-867 Direct & Quantitative HAV Antibody (IgG) ELISA Kit KT-869 Total HAV Antibody ELISA Kit KT-888 Human Intact PTH ELISA Kit KTR-1027 Herpes Simplex Virus Type I & II (HSV-1+2) IgM ELISA Kit KTR-1030 Herpes Simplex Virus Type II (HSV-2) IgG ELISA Kit KTR-1031 Herpes Simplex Virus Type II (HSV-2) IgM ELISA Kit KTR-851 VZV Antibody (IgG) Quantitative ELISA Kit KTR-1028 Herpes Simplex Virus Type I (HSV-1) IgG ELISA Kit KTR-1029 Herpes Simplex Virus Type I (HSV-1) IgM ELISA Kit KTR-1026 Herpes Simplex Virus Type I & II (HSV-1+2) IgG ELISA Kit KT-813 Human Calcitonin ELISA Kit SKT-037 Free Thyroxine CLIA Kit SKT-032 Human Cytokeratin fragment 19 (CYFRA21-1) CLIA Kit SKT-039 Total Thyroxine CLIA Kit EDI CL0812 Human Anti-Mullerian Hormone CLIA Kit CL0804 Human Anti-Mullerian Hormone CLIA Kit KT-804 Human Anti-Mullerian Hormone ELISA Kit SKT-019 Human Estradiol CLIA Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QXT	Infliximab Test System	Clinical Toxicology	Class 2	862.3115	2026-04-30
JRI	Cuvette, Thermostated	Clinical Chemistry	Class 1	862.2050	2024-11-14
DEG	Lactoferrin, Antigen, Antiserum, Control	Immunology	Class 1	866.5570	2026-04-30
MLH	Strip, Hama Igg, Elisa, In Vitro Test System	Immunology	Class 2	866.5510	2008-12-23
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2023-10-09
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2024-11-14
DAJ	Free Secretory Component, Antigen, Antiserum, Control	Immunology	Class 2	866.5380	2026-04-30
QFO	Zika Virus Serological Reagents	Microbiology	Class 2	866.3935	2020-11-13
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2020-01-29
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2024-11-14
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2024-11-14
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2024-11-19
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2010-12-27
QXS	Chromogranin A	Immunology	Class 2	866.6010	2024-11-14
QVP	Sars-Cov-2 Serology Test	Microbiology	Class 2	866.3983	2024-11-20
CKG	Radioimmunoassay, Acth	Clinical Chemistry	Class 2	862.1025	2013-12-16
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2024-11-20
NEO	System, Test, Osteocalcin	Clinical Chemistry	Class 2	862.1050	2008-12-23
LKS	Device, Parasite Concentration	Microbiology	Class 1	866.2900	2024-11-20
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2024-11-19
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2026-03-06
CGC	Radioimmunoassay, Gastrin	Clinical Chemistry	Class 1	862.1325	2024-11-20
QYD	Adalimumab Assay	Clinical Toxicology	Class 2	862.3115	2026-04-30
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2024-11-20
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2024-11-20
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2013-12-16
LOJ	Kit, Test,Alpha-Fetoprotein For Testicular Cancer	Immunology	Class 2	866.6010	2024-11-13
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2024-11-20
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2017-10-05
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2024-11-14
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2024-11-20
PRI	Procalcitonin Assay	Microbiology	Class 2	866.3215	2024-11-13
QAT	Brain Trauma Assessment Test	Immunology	Class 2	866.5830	2026-04-30
NYI	Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer	Immunology	Class 2	866.6040	2024-11-20
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2024-11-20
NTV	Myeloperoxidase, Immunoassay, System, Test	Immunology	Class 2	866.5600	2013-12-16
OIU	Test, Epithelial Ovarian Tumor Associated Antigen (He4)	Immunology	Class 2	866.6010	2024-11-19
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2024-11-20
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2024-11-19
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2024-11-20
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2024-11-13
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2024-11-19
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2024-11-19
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2025-12-09
JLB	Atp And Creatine Kinase (Enzymatic), Creatine	Clinical Chemistry	Class 1	862.1210	2024-11-20
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2024-11-19
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2024-11-14
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2017-07-19
PGI	Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	Microbiology	Class 2	866.3309	2024-11-14
JKR	Radioimmunoassay, Calcitonin	Clinical Chemistry	Class 2	862.1140	2024-11-14
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2024-11-19
OVK	Cytokeratin Fragments 21-1 Eia Kit	Immunology	Class 2	866.6010	2024-11-19
CDX	Radioimmunoassay, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2024-11-20
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2010-12-27
PQO	Anti-Müllerian Hormone Test System	Clinical Chemistry	Class 2	862.1092	2018-01-29
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2024-11-20

Official Correspondent

PING GAO

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EPITOPE DIAGNOSTICS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K850376	Terumo Medical Corp.	TERUMO SENSIBEAD EIA TSH KIT	1985-03-04
K843395	Hybritech, Inc.	ENCORE TSH REAGENT	1984-10-11
K854087	Organon Teknika Corp.	NML TSH IRMA	1985-10-25
K151792	Siemens Healthcare Diagnostics, Inc.	Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System	2015-11-20
K141999	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR TSH	2015-04-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2025	Qualigen Inc	2	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020	Roche Diagnostics Operations, Inc.	2	AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Centaur XPT Immunoassay System
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032839. Last updated year: 2026. Please use registration number 2032839 when referencing this establishment in official correspondence.