FDA device listing
SureSign 10Lh + 25mIU Ovulation and Pregnancy Test,SureSign 5ct 25mIU Single Step Pregnancy Test
FDA device listing 1155722077 · Kingsway Pharmaceuticals dba NFI, LLC
Key facts
| Proprietary names | SureSign 10Lh + 25mIU Ovulation and Pregnancy Test,SureSign 5ct 25mIU Single Step Pregnancy Test |
|---|---|
| Owner/operator | Kingsway Pharmaceuticals dba NFI, LLC |
| Owner/operator number | 10053911 |
| Premarket submissions | K230038 |
| 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 | KINGSWAY PHARMACEUTICALS DBA NFI, LLC |
| Establishment registrations | 3013167221 |
| FEI numbers | 3013167221 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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