UDI device identifier
TopCare Health One Step Pregnancy Test
UDI device identifier 00036800458185 · Topco Associates, LLC
Key facts
| Primary DI | 00036800458185 |
|---|---|
| Brand name | TopCare Health |
| Version or model | One Step Pregnancy Test |
| Company | Topco Associates, LLC |
| DUNS number | 072943876 |
| Product code | LCX |
| GMDN term | Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical |
| Premarket submission | K042280 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jun 10, 2019 |
| Version date | Aug 21, 2026 |
| Description | FPPL TopCare Visual Pregnancy Test +/- 1ct Blue Cap |
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: