FDA device listing
ASSY RGT DISPENSER CARD ISH PROBE,cobas® liat transfer pipette pack kit,Inline User Fillable Kit,Light Protective Prep…
FDA device listing 1698415749 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | ASSY RGT DISPENSER CARD ISH PROBE,cobas® liat transfer pipette pack kit,Inline User Fillable Kit,Light Protective Prep Kit,NEXES REAGENT DISPENSER CARD,Prep Kit |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | JRC |
| Device names | JRC - Micro Pipette |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | ROCHE MOLECULAR SYSTEMS, INC., VENTANA MEDICAL SYSTEMS, INC. |
| Establishment registrations | 2028492, 2243471 |
| FEI numbers | 2243471, 1000125183 |
| Establishment operations | Manufacturer |
| 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