FDA device listing
579-2-RSA Dynamic Interface v1.1.0,713-2-cobase 8100 v1.0.5,770-1-CCM-AOB v1.1.0,Accu-Chek 360° Diabetes Management…
FDA device listing 1557491714 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | 579-2-RSA Dynamic Interface v1.1.0,713-2-cobase 8100 v1.0.5,770-1-CCM-AOB v1.1.0,Accu-Chek 360° Diabetes Management System Professional,Accu-Chek Care,Accu-Chek Care (HCP),Accu-Chek Smart Pix Software,Add-On Buffer Unit,Aliquot Tip Loader,BCM for cobas 8100,B-Gate Interface,Bulk Loader for cobas p 471,Bulk Loader Module for p512/612,c8100 BCL,c8100 Beta,c8100 BRF,c8100 CLO,c8100 CLW,c8100… |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | JQP |
| Device names | JQP - Calculator/Data Processing Module, For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2100 |
| Review panels | Clinical Chemistry |
| Registered establishments | Roche Diabetes Care GmbH, ROCHE DIABETES CARE, INC., Roche Diagnostics Automation Solutions GmbH, ROCHE DIAGNOSTICS GMBH, ROCHE DIAGNOSTICS INTERNATIONAL LTD., Roche Diagnostics Santa Clara, Roche Diagnostics S.L., ROCHE MOLECULAR SYSTEMS, INC. |
| Establishment registrations | 2243471, 9610126, 3003618481, 3003795116, 3009731198, 3010900203, 3011393376, 3011806823 |
| FEI numbers | 2243471, 3002806559, 3003618481, 3003795116, 3009731198, 3010900203, 3011393376, 3011806823 |
| Establishment operations | Foreign Exporter, Manufacturer, Specification Developer |
| 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