FDA device listing
OnSite HBsAg Combo Rapid Test (REF# R0042C),OnSite HBsAg Combo Rapid Test (REF# R0042C-CE),OnSite HBsAg/HCV Ab Rapid…
FDA device listing 1138374970 · CTK BIOTECH, INC.
Key facts
| Proprietary names | OnSite HBsAg Combo Rapid Test (REF# R0042C),OnSite HBsAg Combo Rapid Test (REF# R0042C-CE),OnSite HBsAg/HCV Ab Rapid Test (REF# R0028C),OnSite HBsAg Rapid Test (REF# R0040C),OnSite HBsAg Rapid Test (REF# R0040S),OnSite HBV-5 Rapid Test (REF# R0049C),RecombiLISA HBcAb ELISA (REF# E0810),RecombiLISA HBc IgM ELISA (REF# E0811),RecombiLISA HBeAb ELISA (REF# E0721),RecombiLISA HBeAg ELISA (REF#… |
|---|---|
| Owner/operator | CTK BIOTECH, INC. |
| Owner/operator number | 9051784 |
| Product codes | LOM |
| Device names | LOM - Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3172 |
| Review panels | Microbiology |
| Registered establishments | CTK BIOTECH, INC. |
| Establishment registrations | 2032682 |
| FEI numbers | 3003952975 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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