FDA device listing
BEB LH Ovulation Rapid Test Strip,Famwell LH Ovulation Rapid Test Strip,Famwell LH Rapid Test
FDA device listing 1695495157 · Boston Easy Biotech Inc
Key facts
| Proprietary names | BEB LH Ovulation Rapid Test Strip,Famwell LH Ovulation Rapid Test Strip,Famwell LH Rapid Test |
|---|---|
| Owner/operator | Boston Easy Biotech Inc |
| Owner/operator number | 10086310 |
| Product codes | NGE |
| Device names | NGE - Test, Luteinizing Hormone (Lh), Over The Counter |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1485 |
| Review panels | Clinical Chemistry |
| Registered establishments | BOSTON EASY BIOTECH INC |
| Establishment registrations | 3024753119 |
| FEI numbers | 3024753119 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| 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