FDA device listing
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
FDA device listing 1891356474 · Affinity Biosensors
Key facts
| Proprietary names | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system |
|---|---|
| Owner/operator | Affinity Biosensors |
| Owner/operator number | 10091217 |
| Premarket submissions | K211815 |
| Product codes | LON, SAN |
| Device names | LON - System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, SAN - Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.1645, 866.1650 |
| Review panels | Microbiology |
| Registered establishments | AFFINITY BIOSENSORS |
| Establishment registrations | 3025772277 |
| FEI numbers | 3025772277 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| 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