FDA device listing
ProbeChek Slides 02J27-011,UROVYSION BLADDER C ANCER KIT,UroVysion Bladder Cancer Kit, 100 Assay 02J27-095,UroVysion…
FDA device listing 1436424352 · ABBOTT LABORATORIES
Key facts
| Proprietary names | ProbeChek Slides 02J27-011,UROVYSION BLADDER C ANCER KIT,UroVysion Bladder Cancer Kit, 100 Assay 02J27-095,UroVysion Bladder Cancer Kit, 20 Assay 02J27-025 |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | P030052 |
| Product codes | NSD |
| Device names | NSD - Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.NSD |
| Review panels | Pathology |
| Registered establishments | Abbott Molecular Distribution Center, ABBOTT MOLECULAR, INC. |
| Establishment registrations | 3005248192, 3019837962 |
| FEI numbers | 3005248192, 3019837962 |
| 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