UDI device identifier
E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] 7078
UDI device identifier 00083059070781 · BIOMERICA, INC.
Key facts
| Primary DI | 00083059070781 |
|---|---|
| Brand name | E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] |
| Version or model | 7078 |
| Company | BIOMERICA, INC. |
| DUNS number | 067647321 |
| Product code | KHW |
| GMDN term | Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA) |
| 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 E. histolytica/dispar ELISA is intended for the qualitative detection of Entamoeba specific antigen in fecal specimens. This assay is intended for in vitro diagnostic use only. |
At a glance
- None MAUDE reports citing this UDI
- No Linked premarket submission
- No 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: