FDA device listing
Sofia Strep A FIA
FDA device listing 2037892069 · Scantibodies Laboratory Inc.
Key facts
| Proprietary names | Sofia Strep A FIA |
|---|---|
| Owner/operator | Scantibodies Laboratory Inc. |
| Owner/operator number | 2020808 |
| Product codes | GTY, KHO |
| Device names | GTY - Antigens, All Groups, Streptococcus Spp., KHO - Fluorometer, For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2560, 866.3740 |
| Review panels | Clinical Chemistry, Microbiology |
| Registered establishments | Laboratorios Scantibodies, S.A. de C.V., LABORATORIOS SCANTIBODIES S.A. DE C.V. |
| Establishment registrations | 3002792284, 3033507883 |
| FEI numbers | 3002792284, 3033507883 |
| Establishment operations | Contract Manufacturer |
| 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