FDA device listing
Cubtale Ovulation (LH) Test Strip,FIRSTVIEW Luteinizing Hormone Rapid Test Device,FIRSTVIEW Luteinizing Hormone Rapid…
FDA device listing 1356159589 · Safecare Biotech(Hangzhou)Co.,Ltd
Key facts
| Proprietary names | Cubtale Ovulation (LH) Test Strip,FIRSTVIEW Luteinizing Hormone Rapid Test Device,FIRSTVIEW Luteinizing Hormone Rapid Test Midstream,FIRSTVIEW Luteinizing Hormone Rapid Test Strip,SAFECARE Luteinizing Hormone Rapid Test Device,SAFECARE Luteinizing Hormone Rapid Test Midstream,SAFECARE Luteinizing Hormone Rapid Test Strip,TTestahead Luteinizing Hormone Rapid Test Device,TTestahead Luteinizing… |
|---|---|
| Owner/operator | Safecare Biotech(Hangzhou)Co.,Ltd |
| Owner/operator number | 10052102 |
| 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 | SAFECARE BIOTECH(HANGZHOU)CO.,LTD |
| Establishment registrations | 3013077867 |
| FEI numbers | 3013077867 |
| 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