Epitope Diagnostics, Inc.
San Diego, CA, US
EPITOPE DIAGNOSTICS, INC. appears in FDA device records in San Diego, CA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Epitope Diagnostics, Inc. in 2005.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2032839 | 3004185580 | EPITOPE DIAGNOSTICS, INC. | 17034 Camino San Bernardo, SAN DIEGO, CA 92127 US | 2026 | and 67 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- MSTAntibodies, Gliadin
- GODAntigens, Cf (Including Cf Control), Adenovirus 1-33
- JLBAtp And Creatine Kinase (Enzymatic), Creatine
- MVMAutoantibodies, Endomysial(Tissue Transglutaminase)
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- MHJCryptosporidium Spp.
- JRICuvette, Thermostated
- LKSDevice, Parasite Concentration
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- DBFFerritin, Antigen, Antiserum, Control
- GHHFibrin Split Products
- DAJFree Secretory Component, Antigen, Antiserum, Control
- MHIGiardia Spp.
- DADHaptoglobin, Antigen, Antiserum, Control
- LYRHelicobacter Pylori
- LOLHepatitis A Test (Antibody And Igm Antibody)
- MMIImmunoassay Method, Troponin Subunit
- JNLImmunochemical, Thyroglobulin Autoantibody
- LOJKit, Test,Alpha-Fetoprotein For Testicular Cancer
- DEGLactoferrin, Antigen, Antiserum, Control
- DDRMyoglobin, Antigen, Antiserum, Control
- JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- CDDRadioassay, Vitamin B12
- JLXRadioimmunoassay, 17-Hydroxyprogesterone
- CKGRadioimmunoassay, Acth
- JKDRadioimmunoassay, C-Peptides Of Proinsulin
- JKRRadioimmunoassay, Calcitonin
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CGCRadioimmunoassay, Gastrin
- JMERadioimmunoassay, Glucagon
- CFLRadioimmunoassay, Human Growth Hormone
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- KHEReagent, Occult Blood
- LLHReagents, Clostridium Difficile Toxin
- MVUReagents, Specific, Analyte
- MLHStrip, Hama Igg, Elisa, In Vitro Test System
- NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
- DHXSystem, Test, Carcinoembryonic Antigen
- NCWSystem, Test, Her-2/Neu, Monitoring
- DHASystem, Test, Human Chorionic Gonadotropin
- MOISystem, Test, Immunological, Antigen, Tumor
- NEOSystem, Test, Osteocalcin
- JZOSystem, Test, Thyroid Autoantibody
- MRGSystem, Test, Vitamin D
- LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
- NBCTest, Natriuretic Peptide
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0426-2021 | 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 of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection. | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain