FDA device listing
cobas® CT/NG for use on cobas® 6800/8800 systems,cobas® CT/NG Positive Control Kit,cobas® CT/NG Qualitative nucleic acid…
FDA device listing 1113598221 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas® CT/NG for use on cobas® 6800/8800 systems,cobas® CT/NG Positive Control Kit,cobas® CT/NG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems,cobas® PCR Media Dual Swab Sample Kit,cobas® PCR Media Uni Swab Sample Kit,cobas® PCR Urine Sample Kit,KIT COBAS 58/68/8800 CT/NG 480T IVD,KIT COBAS 58/68/8800 CT/NG RMC IVD,KIT COBAS 6800/8800 CT/NG 480T IVD,KIT COBAS 6800/8800… |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K173887 |
| Product codes | LSL, MKZ, OOI |
| Device names | LSL - Dna-Reagents, Neisseria, MKZ - Dna Probe, Nucleic Acid Amplification, Chlamydia, OOI - Real Time Nucleic Acid Amplification System |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.2570, 866.3120, 866.3390 |
| Review panels | Clinical Chemistry, 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 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