FDA device listing
KIT C58/68/88 CHIKV/DENV 480T CE-IVD,KIT C68/88 CHIKV/DENV 480T CE-IVD,KIT C68/88 CHIKV/DENV RMC CE-IVD,KIT COBAS…
FDA device listing 1828098762 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | KIT C58/68/88 CHIKV/DENV 480T CE-IVD,KIT C68/88 CHIKV/DENV 480T CE-IVD,KIT C68/88 CHIKV/DENV RMC CE-IVD,KIT COBAS 58/68/88 CHIKV/DENV RMC CE-IVD |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | OZB |
| Device names | OZB - Dengue Nucleic Acid Amplification Assay (Naat) |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3946 |
| Review panels | Microbiology |
| Registered establishments | ROCHE MOLECULAR SYSTEMS, INC. |
| Establishment registrations | 2243471 |
| FEI numbers | 2243471 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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