UDI device identifier
Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] 7063
UDI device identifier 00083059070637 · BIOMERICA, INC.
Key facts
| Primary DI | 00083059070637 |
|---|---|
| Brand name | Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] |
| Version or model | 7063 |
| Company | BIOMERICA, INC. |
| DUNS number | 067647321 |
| Product code | MHJ |
| GMDN term | Cryptosporidium species 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 Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium-specific antigen (CSA) 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: