Data / Medical devices / United States / Epitope Diagnostics, Inc.
Epitope Diagnostics, Inc.: FDA-registered device maker in San Diego, CA, United States, 1 510(k) clearance
Epitope Diagnostics, Inc. is registered with the FDA (registration 2032839) in San Diego, CA, United States. It lists 77 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 3, 2005. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2032839
- FEI number
- 3004185580
- Address
- 17034 Camino San Bernardo, San Diego, CA, United States, 92127
- Owner or operator
- EPITOPE DIAGNOSTICS, INC. (9059077)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 11, 2007
- Registered through
- 2026
- Brand names listed
- 30210 Fecal Sample Collection Kit, 30669 Fecal Extraction Buffer, 31315 Stool Sampler, CL0004 Tissue Transglutaminase IgG CLIA Kit, CL0005 Tissue Transglutaminase IgA CLIA Kit, CL0006 Fecal Pancreatic Elastase-1 CLIA Kit, CL0007 EDI Deamidated Gliadin Peptide, IgA CLIA Kit, CL0008 EDI Deamidated Gliadin Peptide, IgG CLIA Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Acid, Folic, Radioimmunoassay | CGN | 2 | Manufacturer for export | accessdata.fda.gov |
| Adalimumab Assay | QYD | 2 | Manufacturer for export | accessdata.fda.gov |
| AlzheimerS Disease Pathology Assessment Test | QSE | 2 | Manufacturer for export | accessdata.fda.gov |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Anti-Müllerian Hormone Test System | PQO | 2 | Manufacturer for export | accessdata.fda.gov |
| Antibodies, Gliadin | MST | 2 | Manufacturer for export | accessdata.fda.gov |
| Antigens, Cf (Including Cf Control), Adenovirus 1-33 | GOD | 1 | Manufacturer | accessdata.fda.gov |
| Atp And Creatine Kinase (Enzymatic), Creatine | JLB | 1 | Manufacturer | accessdata.fda.gov |
| Autoantibodies, Endomysial(Tissue Transglutaminase) | MVM | 2 | Manufacturer for export | accessdata.fda.gov |
| Brain Trauma Assessment Test | QAT | 2 | Manufacturer for export | accessdata.fda.gov |
| Calprotectin, Fecal | NXO | 2 | Manufacturer for export | accessdata.fda.gov |
| Chromogranin A | QXS | 2 | Manufacturer for export | accessdata.fda.gov |
| Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer | NYI | 2 | Manufacturer for export | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Manufacturer | accessdata.fda.gov |
| Cryptosporidium Spp. | MHJ | 2 | Manufacturer | accessdata.fda.gov |
| Cuvette, Thermostated | JRI | 1 | Manufacturer | accessdata.fda.gov |
| Cytokeratin Fragments 21-1 Eia Kit | OVK | 2 | Manufacturer for export | accessdata.fda.gov |
| Device, Parasite Concentration | LKS | 1 | Manufacturer | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Rotavirus | LIQ | 1 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ferritin, Antigen, Antiserum, Control | DBF | 2 | Manufacturer for export | accessdata.fda.gov |
| Fibrin Split Products | GHH | 2 | Manufacturer for export | accessdata.fda.gov |
| Free Secretory Component, Antigen, Antiserum, Control | DAJ | 2 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Giardia Spp. | MHI | 2 | Manufacturer | accessdata.fda.gov |
| Haptoglobin, Antigen, Antiserum, Control | DAD | 2 | Manufacturer for export | accessdata.fda.gov |
| Helicobacter Pylori | LYR | 1 | Manufacturer for export | accessdata.fda.gov |
| Hepatitis A Test (Antibody And Igm Antibody) | LOL | 2 | Manufacturer for export | accessdata.fda.gov |
| Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | PGI | 2 | Manufacturer for export | accessdata.fda.gov |
| Immunoassay Method, Troponin Subunit | MMI | 2 | Manufacturer for export | accessdata.fda.gov |
| Immunochemical, Thyroglobulin Autoantibody | JNL | 2 | Manufacturer for export | accessdata.fda.gov |
| Infliximab Test System | QXT | 2 | Manufacturer for export | accessdata.fda.gov |
| Kit, Test,Alpha-Fetoprotein For Testicular Cancer | LOJ | 2 | Manufacturer for export | accessdata.fda.gov |
| Lactoferrin, Antigen, Antiserum, Control | DEG | 1 | Manufacturer | accessdata.fda.gov |
| Myeloperoxidase, Immunoassay, System, Test | NTV | 2 | Manufacturer for export | accessdata.fda.gov |
| Myoglobin, Antigen, Antiserum, Control | DDR | 2 | Manufacturer for export | accessdata.fda.gov |
| P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | JNN | 1 | Manufacturer | accessdata.fda.gov |
| Procalcitonin Assay | PRI | 2 | Manufacturer for export | accessdata.fda.gov |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioassay, Vitamin B12 | CDD | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Acth | CKG | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Calcitonin | JKR | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Estradiol | CHP | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Free Thyroxine | CEC | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Gastrin | CGC | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Glucagon | JME | 1 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Human Growth Hormone | CFL | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Immunoreactive Insulin | CFP | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Luteinizing Hormone | CEP | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Parathyroid Hormone | CEW | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Progesterone | JLS | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | 1 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Total Thyroxine | CDX | 2 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Total Triiodothyronine | CDP | 2 | Manufacturer | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Manufacturer | accessdata.fda.gov |
| Reagents, Clostridium Difficile Toxin | LLH | 1 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| Sars-Cov-2 Serology Test | QVP | 2 | Manufacturer for export | accessdata.fda.gov |
| Strip, Hama Igg, Elisa, In Vitro Test System | MLH | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | NIG | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Carcinoembryonic Antigen | DHX | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Her-2/Neu, Monitoring | NCW | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Human Chorionic Gonadotropin | DHA | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Immunological, Antigen, Tumor | MOI | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Osteocalcin | NEO | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | PUW | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Thyroid Autoantibody | JZO | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Vitamin D | MRG | 2 | Manufacturer for export | accessdata.fda.gov |
| Test, Epithelial Ovarian Tumor Associated Antigen (He4) | OIU | 2 | Manufacturer for export | accessdata.fda.gov |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | 2 | Manufacturer for export | accessdata.fda.gov |
| Test, Natriuretic Peptide | NBC | 2 | Manufacturer for export | accessdata.fda.gov |
| Zika Virus Serological Reagents | QFO | 2 | Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| October 3, 2005 | K051806 | CARE FECAL OCCULT BLOOD TEST, MODEL KT313 | KHE | Substantially Equivalent | Epitope Diagnostics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|
| October 1, 2020 | 86516 | Class II | Ongoing | EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection | The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value. | accessdata.fda.gov |
Compare with other makers
Updated October 3, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.