UDI device identifier
EZ Detect Colon Disease Test 1000-1
UDI device identifier 00083059100013 · BIOMERICA, INC.
Key facts
| Primary DI | 00083059100013 |
|---|---|
| Brand name | EZ Detect Colon Disease Test |
| Version or model | 1000-1 |
| 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 | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jul 1, 2020 |
| Version date | Nov 28, 2022 |
| Description | Home Test For Hidden Blood in The Stool |
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: