UDI device identifier
EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay] 7025
UDI device identifier 00083059070255 · BIOMERICA, INC.
Key facts
| Primary DI | 00083059070255 |
|---|---|
| Brand name | EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay] |
| Version or model | 7025 |
| Company | BIOMERICA, INC. |
| DUNS number | 067647321 |
| Product code | GGT |
| GMDN term | Erythropoietin (EPO) IVD, reagent |
| Premarket submission | K992799 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jul 1, 2020 |
| Version date | Jul 9, 2020 |
| 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… |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- Yes EUDAMED counterpart found
- 10–99 GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: