FDA device listing
BOND Ready-to-Use Primary Antibody Progesterone Receptor (Clone 16),Novocastra Liquid Mouse Monoclonal Antibody…
FDA device listing 1851624417 · Leica Biosystems, division of Leica Microsystems, Inc.
Key facts
| Proprietary names | BOND Ready-to-Use Primary Antibody Progesterone Receptor (Clone 16),Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 |
|---|---|
| Owner/operator | Leica Biosystems, division of Leica Microsystems, Inc. |
| Owner/operator number | 10054155 |
| Premarket submissions | K062615 |
| Product codes | MXZ |
| Device names | MXZ - Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.1860 |
| Review panels | Hematology |
| Registered establishments | LEICA BIOSYSTEMS NEWCASTLE LTD |
| Establishment registrations | 3004859032 |
| FEI numbers | 3004859032 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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