FDA device listing
hCG One Step Pregnancy Test Cassette,hCG One Step Pregnancy Test Midstream,hCG One Step Pregnancy Test Strip,Sejoy hCG…
FDA device listing 1491569484 · SEJOY BIOMEDICAL CO., LTD.
Key facts
| Proprietary names | hCG One Step Pregnancy Test Cassette,hCG One Step Pregnancy Test Midstream,hCG One Step Pregnancy Test Strip,Sejoy hCG One Step Pregnancy Test Cassette,Sejoy hCG One Step Pregnancy Test Midstream,Sejoy hCG One Step Pregnancy Test Strip,Vivoo At-Home Ovulation & Pregnancy Tests |
|---|---|
| Owner/operator | SEJOY BIOMEDICAL CO., LTD. |
| Owner/operator number | 9078355 |
| Premarket submissions | K212447 |
| 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 | SEJOY BIOMEDICAL CO., LTD. |
| Establishment registrations | 3005395953 |
| FEI numbers | 3005395953 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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