UDI device identifier
EZ Detect Fecal Occult Blood Test 1001
UDI device identifier 00083059010015 · BIOMERICA, INC.
Key facts
| Primary DI | 00083059010015 |
|---|---|
| Brand name | EZ Detect Fecal Occult Blood Test |
| Version or model | 1001 |
| Company | BIOMERICA, INC. |
| DUNS number | 067647321 |
| Product code | KHE |
| GMDN term | Faecal occult blood IVD, kit, rapid colorimetric, clinical |
| Premarket submission | K860028 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jul 1, 2020 |
| Version date | Nov 28, 2022 |
| Description | The EZ DETECT Test is for in vitro qualitative detection of occult blood in the stool -- an early indicator of various gastrointestinal bleeding disorders. The test is dispensed by the physician to the patient for home use. |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- Yes EUDAMED counterpart found
- 100–999 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: