UDI device identifier
EZ-hCG Urine Pregnancy Test 1048-25
UDI device identifier 00083059104851 · BIOMERICA, INC.
Key facts
| Primary DI | 00083059104851 |
|---|---|
| Brand name | EZ-hCG Urine Pregnancy Test |
| Version or model | 1048-25 |
| Company | BIOMERICA, INC. |
| DUNS number | 067647321 |
| Product code | JHI |
| GMDN term | Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid |
| Premarket submission | K003856 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jul 1, 2020 |
| Version date | Jul 9, 2020 |
| Description | The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No 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: