FDA device listing
cobas CT/NG Test, v2.0,cobas z 480 Analyzer,KIT COBAS PCR MEDIA UNI SWB 100 PKT IVD,SW c4800 CT/NG AP V. 2.1.0 CD
FDA device listing 1007000899 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas CT/NG Test, v2.0,cobas z 480 Analyzer,KIT COBAS PCR MEDIA UNI SWB 100 PKT IVD,SW c4800 CT/NG AP V. 2.1.0 CD |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K132270 |
| 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