FDA device listing
cobas® SARS-CoV-2 - 480T,cobas® SARS-CoV-2 & Influenza A/B Control Kit,cobas® SARS-CoV-2 & Influenza A/B for use on the…
FDA device listing 1959539902 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas® SARS-CoV-2 - 480T,cobas® SARS-CoV-2 & Influenza A/B Control Kit,cobas® SARS-CoV-2 & Influenza A/B for use on the cobas® 6800/8800 Systems,cobas® SARS-CoV-2 Quality Control Kit,KIT C68/88 SARS-COV2 DUO 192T,KIT C68/88 SARS-COV2 DUO RMC,KIT COBAS 58/68/8800 SARS-COV-2/FLU RMC,KIT COBAS 58/68/8800 SARSCOV2FLUV2 192T,KIT COBAS 6800/8800 SARS-COV-2 192T,KIT COBAS 6800/8800 SARS-COV-2 480T,KIT… |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | QJR |
| Device names | QJR - Reagents, 2019-Novel Coronavirus Nucleic Acid |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.QJR |
| Review panels | Microbiology |
| 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