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Sign in to claim this brandLeica Biosystems Newcastle, Limited
US
Last updated May 23, 2026
What Leica Biosystems Newcastle, Limited makes
The company manufactures in vitro diagnostic (IVD) antibody reagents and automated immunohistochemistry (IHC) systems for tissue analysis, including cytokeratin, estrogen/progesterone receptors, kappa/lambda light chains, Ki67, CD45, CD117, and CD20 markers. These products support pathology workflows for cancer diagnostics, cell marker identification, and receptor assessment in clinical laboratories.
The portfolio includes Class I, Class II, and Class III devices, all listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Leica Biosystems Newcastle, Limited manufacture?
Leica Biosystems Newcastle, Limited specializes in in vitro diagnostic (IVD) products, specifically antibody reagents and automated immunohistochemistry (IHC) systems. Their devices focus on tissue analysis for pathology workflows, including markers like cytokeratin, estrogen/progesterone receptors, kappa/lambda light chains, Ki67, CD45, CD117, and CD20. These tools are primarily used in cancer diagnostics and receptor assessment within clinical laboratories.
Where is Leica Biosystems Newcastle, Limited based?
The company is based in the United States. While the name includes 'Newcastle,' this refers to a specific location or division within the US rather than an international headquarters.
Which regulatory registries list Leica Biosystems Newcastle, Limited’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry tracks Class I, II, and III devices, ensuring traceability and compliance for authorized products.
How are Leica Biosystems Newcastle, Limited’s devices classified under regulatory standards?
The company’s devices fall into three regulatory classes: Class I (generally low-risk), Class II (moderate risk with special controls), and Class III (high-risk requiring premarket approval). Classification depends on factors like the device’s purpose, intended use, and potential health impact, as defined by regulatory authorities.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (546)
Page 11 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Novocastra™ | FXIIIA-L-U | FDA UDI | Class I | Active |
| Bond | PA0016-U | FDA UDI | Class I | Active |
| Bond™ | PA0620 | FDA UDI | Class I | Active |
| Bond™ | PA0488-U | FDA UDI | Class I | Active |
| Acd | RS7756 | FDA UDI | Class I | Active |
| Bond™ | PA0906 | FDA UDI | Class I | Active |
| Bond™ | PA0131 | FDA UDI | Class I | Active |
| Bond | PA0473-U | FDA UDI | Class I | Active |
| Bond™ | PA0736 | FDA UDI | Class I | Unknown |
| Bond™ | PA0171-U | FDA UDI | Class I | Active |
| Bond™ | PA0067-U | FDA UDI | Class I | Active |
| Bond™ | PA0151 | EUDAMEDFDA UDI | Class II | Active |
| Bond™ | PA0046 | EUDAMEDFDA UDI | Class I | Active |
| Bond™ | PA0431 | FDA UDI | Class I | Active |
| Acd | RS7755 | FDA UDI | Class I | Active |
| Bond™ | PA0832 | EUDAMEDFDA UDI | Class I | Active |
| Bond™ | PA0843 | EUDAMEDFDA UDI | Class I | Active |
| Acd | RS7861 | FDA UDI | Class I | Active |
| Bond™ | PA0094 | EUDAMEDFDA UDI | Class I | Active |
| Bond™ | PA0009-U | FDA UDI | Class II | Active |
| Bond™ | PA0026 | FDA UDI | Class I | Active |
| Bond™ | PA0776 | FDA UDI | Class I | Unknown |
| Bond™ | PA0373-U | FDA UDI | Class I | Active |
| Bond™ | PA0938 | FDA UDI | Class I | Active |
| Bond™ | PA0155-U | FDA UDI | Class I | Active |
| Bond™ | PA0790 | EUDAMEDFDA UDI | Class I | Active |
| Bond™ | PA0183 | EUDAMEDFDA UDI | Class I | Active |
| Bond™ | PA0991-X | FDA UDI | Class I | Active |
| Bond™ | PA0093-U | FDA UDI | Class I | Active |
| Bond™ | PA0435-U | FDA UDI | Class I | Active |
| Bond™ | PA0258-U | FDA UDI | Class I | Active |
| Bond™ | PA0117 | FDA UDI | Class I | Active |
| Bond™ | PA0271 | FDA UDI | Class I | Active |
| Bond™ | PA0444-U | FDA UDI | Class I | Active |
| Bond™ | PB0780 | EUDAMEDFDA UDI | Class I | Active |
| Bond™ | PA0118 | EUDAMEDFDA UDI | Class I | Active |
| Bond™ | PA0037 | FDA UDI | Class I | Active |
| Bond™ | PA0226-U | FDA UDI | Class I | Active |
| Bond™ | PA0435 | FDA UDI | Class I | Active |
| Bond™ | PA0831 | FDA UDI | Class I | Active |
| Bond™ | PA0704 | FDA UDI | Class I | Active |
| Bond™ | PA0427 | EUDAMEDFDA UDI | Class I | Active |
| Bond™ | PA0570 | EUDAMEDFDA UDI | Class I | Active |
| BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody | K183102 | FDA 510(k) | Class II | Active |
| Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra | K183100 | FDA 510(k) | Class II | Active |
| BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 | K171753 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
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Importers
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Notified Bodies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Leica Biosystems Newcastle Ltd NEWCASTLE UPON TYNE · GB FEI 3004859032