UDI device identifier
GAP®-IgG (Gastritis and Peptic Ulcer Test) 7004
UDI device identifier 00083059070040 · BIOMERICA, INC.
Key facts
| Primary DI | 00083059070040 |
|---|---|
| Brand name | GAP®-IgG (Gastritis and Peptic Ulcer Test) |
| Version or model | 7004 |
| Company | BIOMERICA, INC. |
| DUNS number | 067647321 |
| Product code | LYR |
| GMDN term | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| Premarket submission | K915185 |
| Device class | Class I |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jul 1, 2020 |
| Version date | Jul 9, 2020 |
| Description | The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori. |
At a glance
- None MAUDE reports citing this UDI
- Yes 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: