FDA device listing
LetsGetChecked Urine Sample Collection Kit
FDA device listing 1808650466 · LetsGetChecked Inc.
Key facts
| Proprietary names | LetsGetChecked Urine Sample Collection Kit |
|---|---|
| Owner/operator | LetsGetChecked Inc. |
| Owner/operator number | 10056783 |
| Product codes | OIE |
| Device names | OIE - Urine Collection Kit (Excludes Hiv Testing) |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3250 |
| Review panels | Pathology |
| Registered establishments | LetsGetChecked Inc, LetsGetChecked Inc., Privapath Diagnostics Ltd |
| Establishment registrations | 3015209536, 3020139194, 3042854290 |
| FEI numbers | 3015209536, 3020139194, 3042854290 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database