FDA device listing
PREGMATE Ovulation LH Test,True Level Ovulation LH Test
FDA device listing 1123189652 · PREGMATE LLC
Key facts
| Proprietary names | PREGMATE Ovulation LH Test,True Level Ovulation LH Test |
|---|---|
| Owner/operator | PREGMATE LLC |
| Owner/operator number | 10055200 |
| Product codes | CEP |
| Device names | CEP - Radioimmunoassay, Luteinizing Hormone |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1485 |
| Review panels | Clinical Chemistry |
| Registered establishments | PREGMATE LLC |
| Establishment registrations | 3013679502 |
| FEI numbers | 3013679502 |
| Establishment operations | Repackager/Relabeler |
| 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