UDI device identifier
TRUE+ A1CNow Self Check 3075
UDI device identifier 00021292015022 · POLYMER TECHNOLOGY SYSTEMS, INC.
Key facts
| Primary DI | 00021292015022 |
|---|---|
| Brand name | TRUE+ A1CNow Self Check |
| Version or model | 3075 |
| Catalog number | 3075 |
| Company | POLYMER TECHNOLOGY SYSTEMS, INC. |
| DUNS number | 835772872 |
| Product code | LCP |
| GMDN term | Glycated haemoglobin (HbA1c) monitoring system IVD, home-use |
| Premarket submission | K090413 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jul 30, 2023 |
| Version date | Sep 13, 2023 |
| Description | The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples. |
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: