FDA device listing
2San Digital Early Pregnancy Test,Atida Digital Early Pregnancy Test,Citest Digital Early Pregnancy Home Test,Identify…
FDA device listing 1892271953 · Hangzhou AllTest Biotech Co.,Ltd
Key facts
| Proprietary names | 2San Digital Early Pregnancy Test,Atida Digital Early Pregnancy Test,Citest Digital Early Pregnancy Home Test,Identify Health Digital Early Pregnancy Test,Optilyte Plus Digital Early Pregnancy Rapid Test,QuickScreen At Home Digital Early Pregnancy Test,Shinetell Plus Digital Early Pregnancy Test |
|---|---|
| Owner/operator | Hangzhou AllTest Biotech Co.,Ltd |
| Owner/operator number | 10050156 |
| Premarket submissions | K251053 |
| Product codes | LCX |
| Device names | LCX - Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1155 |
| 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
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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