UDI device identifier
HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT 7033
UDI device identifier 00083059070330 · BIOMERICA, INC.
Key facts
| Primary DI | 00083059070330 |
|---|---|
| Brand name | HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT |
| Version or model | 7033 |
| Company | BIOMERICA, INC. |
| DUNS number | 067647321 |
| Product code | DCK |
| GMDN term | C-reactive protein (CRP) IVD, kit, spectrophotometry |
| Premarket submission | K003851 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jul 1, 2020 |
| Version date | Jul 6, 2023 |
| Description | The hsCRP ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum. Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. |
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: