Establishment registration
GENMARK DIAGNOSTICS, INC.
FDA establishment registration 3008632402 · Carlsbad, US
Key facts
| Registration number | 3008632402 |
|---|---|
| Establishment name | GENMARK DIAGNOSTICS, INC. |
| Owner/operator | GenMark Diagnostics, Inc. |
| Owner/operator number | 9056858 |
| FEI number | 3008632402 |
| Address | GenMark Diagnostics, Inc. |
| City | Carlsbad |
| State | CA |
| Country | US |
| Establishment types | Export-only manufacturer |
| Registration valid through | 2026 |
| Product codes listed | NSU, OCC, OEM, OEP, OOU, OQW, OTG, OZE, OZX, OZY, PAM, PEN, PEO, QJR, QOF |
| Device classes | 2, N |
At a glance
- 1–9 Device listings
- 100–999 UDI devices (GUDID)
- Current Registration current
- 1–9 FDA inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device establishment registrations
Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database