FDA device listing
AccuHome,AimStep,AimStrip,Mosie Baby Ovulation Test
FDA device listing 1275243566 · GERMAINE LABORATORIES, INC.
Key facts
| Proprietary names | AccuHome,AimStep,AimStrip,Mosie Baby Ovulation Test |
|---|---|
| Owner/operator | GERMAINE LABORATORIES, INC. |
| Owner/operator number | 9031523 |
| 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 | GERMAINE LABORATORIES, INC. |
| Establishment registrations | 1649661 |
| FEI numbers | 3001451797 |
| Establishment operations | Manufacturer, 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