FDA device listing
BERKELEY HEALTH Ovulation LH Test,Digital LH Ovulation Test Strip,Ovulation (LH) Rapid Test Cassette,Ovulation (LH)…
FDA device listing 1781942445 · Hangzhou AllTest Biotech Co.,Ltd
Key facts
| Proprietary names | BERKELEY HEALTH Ovulation LH Test,Digital LH Ovulation Test Strip,Ovulation (LH) Rapid Test Cassette,Ovulation (LH) Rapid Test Dipstick,Ovulation (LH) Rapid Test Midstream,QuickScreen At Home Digital Ovulation Test |
|---|---|
| Owner/operator | Hangzhou AllTest Biotech Co.,Ltd |
| Owner/operator number | 10050156 |
| 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 | Hangzhou AllTest Biotech Co.,Ltd |
| Establishment registrations | 3012073813, 3027519599, 3043127647 |
| FEI numbers | 3012073813, 3027519599, 3043127647 |
| Establishment operations | Manufacturer |
| 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