FDA device listing
LetsGetChecked Blood and Saliva Collection Kit,LetsGetChecked Blood and Urine Collection Kit,LetsGetChecked Blood Sample…
FDA device listing 1041469549 · LetsGetChecked Inc.
Key facts
| Proprietary names | LetsGetChecked Blood and Saliva Collection Kit,LetsGetChecked Blood and Urine Collection Kit,LetsGetChecked Blood Sample Collection Kit |
|---|---|
| Owner/operator | LetsGetChecked Inc. |
| Owner/operator number | 10056783 |
| Product codes | PQD |
| Device names | PQD - Blood Specimen Collection Convenience Kit (Excludes Hiv) |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1675 |
| Review panels | Clinical Chemistry |
| 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