UDI device identifier
TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT 7031
UDI device identifier 00083059070316 · BIOMERICA, INC.
Key facts
| Primary DI | 00083059070316 |
|---|---|
| Brand name | TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT |
| Version or model | 7031 |
| Company | BIOMERICA, INC. |
| DUNS number | 067647321 |
| Product code | MMI |
| GMDN term | Troponin T/Troponin I IVD, kit, enzyme immunoassay (EIA) |
| Premarket submission | K013062 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jul 1, 2020 |
| Version date | Jul 9, 2020 |
| Description | The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI). |
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: