FDA device listing
Alinity i ROMA (LN 03R7521),ARCHITECT ROMA (LN 6P30-21)
FDA device listing 1457141733 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity i ROMA (LN 03R7521),ARCHITECT ROMA (LN 6P30-21) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K151502 |
| Product codes | ONX |
| Device names | ONX - Ovarian Adnexal Mass Assessment Score Test System |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.6050 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | ABBOTT GmbH, ABBOTT LABORATORIES |
| Establishment registrations | 1415939, 3002809144, 3005333358 |
| FEI numbers | 1415939, 3002809144, 3005333358 |
| 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