FDA device listing
xTAG Cystic Fibrosis 60 kit v2
FDA device listing 1548656302 · Luminex Corporation
Key facts
| Proprietary names | xTAG Cystic Fibrosis 60 kit v2 |
|---|---|
| Owner/operator | Luminex Corporation |
| Owner/operator number | 9032042 |
| Premarket submissions | K083845 |
| Product codes | NUA |
| Device names | NUA - System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5900 |
| Review panels | Immunology |
| Registered establishments | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| Establishment registrations | 3002777243 |
| FEI numbers | 3002777243 |
| 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