FDA device listing
cobas 5800 instrument,cobas 6800 instrument,cobas 8800 instrument,Digital LC Analyzer,Digital LC Partitioning…
FDA device listing 1273639106 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas 5800 instrument,cobas 6800 instrument,cobas 8800 instrument,Digital LC Analyzer,Digital LC Partitioning Engine,Digital LightCycler® Analyzer,KIT COBAS 58/68/8800 BUFF NEG RMC,KIT COBAS 6800/8800 BUFF NEG RMC IVD,KIT COBAS 6800/8800 UTIL CHAN 96T IVD,LightCycler PRO, 384,LightCycler PRO, 96 |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | NSU |
| Device names | NSU - Instrumentation For Clinical Multiplex Test Systems |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570 |
| Review panels | Clinical Chemistry |
| Registered establishments | ROCHE DIAGNOSTICS GMBH, ROCHE DIAGNOSTICS INTERNATIONAL LTD., ROCHE MOLECULAR SYSTEMS, INC. |
| Establishment registrations | 2243471, 9610126, 3003795116, 3004141078 |
| FEI numbers | 2243471, 3002806559, 3003795116, 3004141078 |
| 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