FDA device listing
03755525001, SPU,05534941001, Cobas Omni Amplification Plate, 12102137001, Assay Tip/Cup Elecsys Modular, 03137082001…
FDA device listing 1608084200 · Flextronics International USA, Inc.
Key facts
| Proprietary names | 03755525001, SPU,05534941001, Cobas Omni Amplification Plate, 12102137001, Assay Tip/Cup Elecsys Modular, 03137082001, Tube-K Box of 12x9,06241620001, MagNA Pure Tip 1000?L,08863504001, Assay Tip tray,11706799001 Assay Tip Elecsys, 11706802001 Assay Cup Elecsys, 05694302001 AssayTip/AssayCup tray (E2G) |
|---|---|
| Owner/operator | Flextronics International USA, Inc. |
| Owner/operator number | 9006592 |
| Product codes | LXG |
| Device names | LXG - Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | Flex Precision Plastics Solutions AG, Flex Precision Plastics Solutions (Switzerland) AG, Flextronics Medical Molding (Shenzhen) Co., Ltd |
| Establishment registrations | 3003027964, 3021010223, 3022473387 |
| FEI numbers | 3003027964, 3021010223, 3022473387 |
| 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