EPITOPE DIAGNOSTICS, INC.
Registration 2032839FEI 3004185580SAN DIEGO, CA
Owner/operator: EPITOPE DIAGNOSTICS, INC.
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Device in the United States for Export Only
- Manufacture Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 77
- Added, last 12 months
- 7
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 77
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| CGN | KT 717 EDI Folate ELISA KitAcid, Folic, Radioimmunoassay | Class 2 | 21 CFR 862.1295 | — |
| QYD | CL0014 EDI Adalimumab CLIA KitAdalimumab AssayAdded Apr 30, 2026 | Class 2 | 21 CFR 862.3115 | — |
| QSE | CL0079 Beta-amyloid (1-40) CLIA KitAlzheimerS Disease Pathology Assessment Test | Class 2 | 21 CFR 866.5840 | — |
| PQO | CL0804 Human Anti-Mullerian Hormone CLIA KitAnti-Müllerian Hormone Test System | Class 2 | 21 CFR 862.1092 | — |
| MST | CL0007 EDI Deamidated Gliadin Peptide, IgA CLIA KitAntibodies, Gliadin | Class 2 | 21 CFR 866.5750 | — |
| MVM | CL0004 Tissue Transglutaminase IgG CLIA KitAutoantibodies, Endomysial(Tissue Transglutaminase) | Class 2 | 21 CFR 866.5660 | — |
| QAT | CL0013 EDI Glial Fibrillary Acidic Protein CLIA kitBrain Trauma Assessment TestAdded Apr 30, 2026 | Class 2 | 21 CFR 866.5830 | — |
| NXO | CL0849 Human Calprotectin CLIA KitCalprotectin, Fecal | Class 2 | 21 CFR 866.5180 | — |
| QXS | CL0820 Human Chromogranin A CLIA KitChromogranin A | Class 2 | 21 CFR 866.6010 | — |
| NYI | SKT-056 Cancer Antigen 15-3 (CA15-3) CLIA KitClassifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer | Class 2 | 21 CFR 866.6040 | — |
| MHJ | CL0814 Fecal Cryptosporidium parvum Antigen CLIA KitCryptosporidium Spp. | Class 2 | 21 CFR 866.3220 | — |
| OVK | SKT-032 Human Cytokeratin fragment 19 (CYFRA21-1) CLIA KitCytokeratin Fragments 21-1 Eia Kit | Class 2 | 21 CFR 866.6010 | — |
and 65 more on your full dossier
What changed
- Apr 30, 2026Listing added: QYD — CL0014 EDI Adalimumab CLIA Kit
- Apr 30, 2026Listing added: QAT — CL0013 EDI Glial Fibrillary Acidic Protein CLIA kit
- Apr 30, 2026Listing added: DAJ — CL0012 EDI Fecal Secretory IgA CLIA Kit
- Apr 30, 2026Listing added: QXT — CL0009 EDIInfliximab CLIA Kit
- Dec 9, 2025Listing added: NNK — 30210 Fecal Sample Collection Kit
- Apr 30, 2026Listing added: DEG — CL0011 EDI Fecal Lactoferrin CLIA Kit
- Mar 6, 2026Listing added: JLX — CL0817 EDI 17-OH-Progesterone CLIA Kit