FDA device listing
A1CD, cobas c 503,Accelerator I 1 x 100ML,Acid Wash Solution,Acid wash Solution 2x1,8 L,Acid wash Solution 2x2…
FDA device listing 1317542115 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | A1CD, cobas c 503,Accelerator I 1 x 100ML,Acid Wash Solution,Acid wash Solution 2x1,8 L,Acid wash Solution 2x2 L,Activator for cobas c,Integra,c111,Alu Positive Control Probe II,Antibody Dilution Buffer,Antigen Excess Reagent,BASIC WASH 2x2 L,Benchmark Special Stains Cleaning Kit,BenchMark Special Stains Deparaffinization Solution (10X),BenchMark Special Stains Liquid Coverslip,BlankCell… |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | PPM |
| Device names | PPM - General Purpose Reagent |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4010 |
| Review panels | Pathology |
| Registered establishments | ROCHE DIAGNOSTICS GMBH, ROCHE DIAGNOSTICS INTERNATIONAL LTD., Roche Diagnostics (Suzhou) Ltd., ROCHE MOLECULAR SYSTEMS, INC., VENTANA MEDICAL SYSTEMS, INC. |
| Establishment registrations | 2028492, 2243471, 9610126, 9610529, 3003795116, 3004141078, 3020917535 |
| FEI numbers | 2243471, 1000125183, 3002806559, 3002806560, 3003795116, 3004141078, 3020917535 |
| Establishment operations | Foreign Exporter, Manufacturer, Repackager/Relabeler, Specification Developer |
| 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