Identity
- Trade Name
- EPO (Erythropoietin) ELISA EUDAMEDEPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay] FDA UDI
- Generic Name
- Erythropoietin (EPO) IVD, reagent FDA UDI
- Device Name
- EPO (Erythropoietin) ELISA EUDAMEDThe Biomerica EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias. FDA UDI
- Model / Reference
- 7025 EUDAMEDFDA UDI
- Description
- The Biomerica EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00083059070255 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00083059070255 EUDAMED
- 510(k) Number
- K992799 FDA UDI
- FDA Product Code
- GGT FDA UDI
- EMDN Code
- W0102070101 ERYTHROPOIETIN EUDAMED
- GMDN Term
- Erythropoietin (EPO) IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7250 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
EPO (Erythropoietin) ELISA by Biomerica, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00083059070255 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Biomerica, Inc.
- EUDAMED SRN
- US-MF-000015772
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 4cf30320-696c-4aa9-b175-292167091cc5 61 fields · synced Jun 19, 2026
- FDA UDI d3a34143-ec0c-4c3a-bc12-f048acaee12a 35 fields · synced May 25, 2026