FDA device listing
Amplification Kit,anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody,anti-bcl-2 (SP66) Rabbit Monoclonal Primary…
FDA device listing 1367743876 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | Amplification Kit,anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody,anti-bcl-2 (SP66) Rabbit Monoclonal Primary Antibody,anti-CD117 (EP10) Rabbit Monoclonal Primary Antibody,anti-CD30 (Ber-H2) Mouse Monoclonal Primary Antibody,Anti-CD43 (L60) Mouse Monoclonal Primary Antibody,anti-CD44 (SP37) Rabbit Monoclonal Primary Antibody,anti-CD7 (SP94) Rabbit Monoclonal Primary Antibody,anti-CEA (TF 3H8-1)… |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | NJT |
| Device names | NJT - Immunohistochemistry Reagents And Kits |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.1860 |
| Review panels | Hematology |
| Registered establishments | ROCHE DIAGNOSTICS GMBH, VENTANA MEDICAL SYSTEMS, INC. |
| Establishment registrations | 2028492, 9610126, 9610529 |
| FEI numbers | 1000125183, 3002806559, 3002806560 |
| Establishment operations | Foreign Exporter, 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