FDA device listing
Antisera, Control For Nontreponemal Tests
FDA device listing 1358718965 · Diagnostic Automation /Cortez Diagnostics Inc.
Key facts
| Owner/operator | Diagnostic Automation /Cortez Diagnostics Inc. |
|---|---|
| Owner/operator number | 9011974 |
| Premarket submissions | K851504 |
| Product codes | GMP |
| Device names | GMP - Antisera, Control For Nontreponemal Tests |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3820 |
| Review panels | Microbiology |
| Registered establishments | Diagnostic Automation/ Cortez Diagnostics Inc,. |
| Establishment registrations | 2029372 |
| FEI numbers | 1000306617 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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