FDA device listing
OnSite Chagas Ab Combo Rapid Test (REF# R0171C),RecombiLISA Chagas IgG ELISA (REF# E0170)
FDA device listing 1796091817 · CTK BIOTECH, INC.
Key facts
| Proprietary names | OnSite Chagas Ab Combo Rapid Test (REF# R0171C),RecombiLISA Chagas IgG ELISA (REF# E0170) |
|---|---|
| Owner/operator | CTK BIOTECH, INC. |
| Owner/operator number | 9051784 |
| Product codes | GND |
| Device names | GND - Antigen, Iha, T. Cruzi |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3870 |
| 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