FDA device listing
FaStep Early Pregnancy Rapid Test Cassette,FaStep Early Pregnancy Rapid Test Midstream,FaStep Early Pregnancy Rapid Test…
FDA device listing 1684680754 · Assure Tech LLC
Key facts
| Proprietary names | FaStep Early Pregnancy Rapid Test Cassette,FaStep Early Pregnancy Rapid Test Midstream,FaStep Early Pregnancy Rapid Test Strip |
|---|---|
| Owner/operator | Assure Tech LLC |
| Owner/operator number | 10090182 |
| Premarket submissions | K243573 |
| Product codes | LCX |
| Device names | LCX - Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1155 |
| Review panels | Clinical Chemistry |
| Registered establishments | ASSURE TECH LLC |
| Establishment registrations | 3030648160 |
| FEI numbers | 3030648160 |
| Establishment operations | Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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