FDA device listing
CL Detect Rapid Test
FDA device listing 1999490068 · INBIOS INTERNATIONAL, INC.
Key facts
| Proprietary names | CL Detect Rapid Test |
|---|---|
| Owner/operator | INBIOS INTERNATIONAL, INC. |
| Owner/operator number | 9032122 |
| Premarket submissions | K141341 |
| Product codes | PIT |
| Device names | PIT - Leishmania Spp. Antigen Detection Assay |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3870 |
| Review panels | Microbiology |
| Registered establishments | INBIOS INTERNATIONAL, INC. |
| Establishment registrations | 3032562 |
| FEI numbers | 3002606748 |
| 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