FDA device listing
AMS100 - MAGELLAN® Autologous Platelet Separator System,AMS300 - MAGELLAN® Complete Disposable Kit,BTI200 - AUTOSPIN™…
FDA device listing 1674002612 · Arteriocyte Medical Systems, Inc.
Key facts
| Proprietary names | AMS100 - MAGELLAN® Autologous Platelet Separator System,AMS300 - MAGELLAN® Complete Disposable Kit,BTI200 - AUTOSPIN™ MAGELLAN® Autologous Platelet Separator System,MAG200 - MAGELLAN® Autologous Platelet Separator System,MAR01 - MAGELLAN® Surgical Tools for Erythrocyte and Marrow Preparation Kit,MAR01-O-105 Magellan® Surgical Tools for Erythrocyte and Marrow Preparation Kit,MAR01-O-25 Magellan®… |
|---|---|
| Owner/operator | Arteriocyte Medical Systems, Inc. |
| Owner/operator number | 10023471 |
| Premarket submissions | BK040068 |
| Product codes | JQC |
| Device names | JQC - Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | Arteriocyte Medical Systems, Inc. |
| Establishment registrations | 3006788678 |
| FEI numbers | 3006788678 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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