FDA device listing
cobas® eplex blood culture identification gram negative (BCID-GN) panel,ePlex Blood Culture Identification Gram Negative…
FDA device listing 1834710033 · GenMark Diagnostics, Inc.
Key facts
| Proprietary names | cobas® eplex blood culture identification gram negative (BCID-GN) panel,ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel |
|---|---|
| Owner/operator | GenMark Diagnostics, Inc. |
| Owner/operator number | 9056858 |
| Premarket submissions | K182619 |
| Product codes | PAM, PEN, PEO |
| Device names | PAM - Gram-Positive Bacteria And Their Resistance Markers, PEN - Gram-Negative Bacteria And Associated Resistance Markers, PEO - Fungal Organisms, Nucleic Acid-Based Assay |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3365 |
| Review panels | Microbiology |
| Registered establishments | GENMARK DIAGNOSTICS, INC. |
| Establishment registrations | 3008632402 |
| FEI numbers | 3008632402 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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