UDI device identifier
Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] 7022
UDI device identifier 00083059070224 · BIOMERICA, INC.
Key facts
| Primary DI | 00083059070224 |
|---|---|
| Brand name | Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] |
| Version or model | 7022 |
| Company | BIOMERICA, INC. |
| DUNS number | 067647321 |
| Product code | CEW |
| GMDN term | Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) |
| Premarket submission | K974306 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jul 1, 2020 |
| Version date | Jul 9, 2020 |
| Description | The Biomerica Intact-PTH ELISA is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum. This assay is intended for in vitro diagnostic use. |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- Yes 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: