UDI device identifier
Hp Detect Stool Antigen ELISA 7083
UDI device identifier 00083059070835 · BIOMERICA, INC.
Key facts
| Primary DI | 00083059070835 |
|---|---|
| Brand name | Hp Detect Stool Antigen ELISA |
| Version or model | 7083 |
| Catalog number | 7083 |
| Company | BIOMERICA, INC. |
| DUNS number | 067647321 |
| Product code | LYR |
| GMDN term | Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) |
| Premarket submission | K232892 |
| Device class | Class I |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jan 8, 2024 |
| Version date | Jan 16, 2024 |
| Description | The Hp Detect™ Stool Antigen ELISA is an in vitro diagnostic qualitative enzyme immunoassay for the detection of Helicobacter pylori (H. pylori) antigens in human stool or feces. The Hp Detect™ Stool Antigen ELISA is intended to aid in the initial diagnosis and post-therapy diagnosis of H. pylori… |
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: