UDI device identifier
Anti-SS-B ELISA EIA-3576
UDI device identifier 00084023903579 · DRG International Inc
Key facts
| Primary DI | 00084023903579 |
|---|---|
| Brand name | Anti-SS-B ELISA |
| Version or model | EIA-3576 |
| Catalog number | EIA-3576 |
| Company | DRG International Inc |
| DUNS number | 075150847 |
| Product code | LJM |
| GMDN term | Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) |
| Premarket submission | K962052 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Aug 25, 2023 |
| Version date | Oct 10, 2023 |
| Description | Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-B (La) in human serum or plasma. |
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: