Leica Biosystems Newcastle, Limited
United Kingdom GB-MF-000020595 Last updated 25 Oct 2026
- Devices
- 959
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 1
Catalogue
Bond PA0265-U Ref PA0265-U
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BOND-PRIME Cleaning Kit Ref CS9300
Tissue Digestion Kit II Ref KBI-60004
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Novocastra™ PSA-431-L-CE Ref PSA-431-L-CE
Novocastra™ LP34-L-U Ref LP34-L-U
Kreatech FISH probes 22Q003B495 Ref 22Q003B495
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BOND ORACLE HER2 IHC System TA9145 Ref TA9145
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Kreatech FISH probes 16P002V550 Ref 16P002V550
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Kreatech FISH probes 01Q005V550 Ref 01Q005V550
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Novocastra™ CK20-L-CE-H Ref CK20-L-CE-H
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Novocastra™ VIM-572-L-CE Ref VIM-572-L-CE
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Novocastra™ MYOD1-L-U Ref MYOD1-L-U
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Novocastra PTH-488-L-U Ref PTH-488-L-U
Novocastra MSH2-612-L-U Ref MSH2-612-L-U
Novocastra™ AE1/AE3-L-CE Ref AE1/AE3-L-CE
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Showing 1-50 of 959
EUDAMED certificates
Notified body 2797 1 certificate
- IVDR 739320 Reissued
Quality management system EU IVDR
- Issued
- 1 Jun 2026
- Expires
- 7 Jun 2031
- Valid from
- 8 Jun 2026
Related companies
Authorised representatives
- CEpartner4U NL
Notified bodies
- Notified body 2797
FDA recalls
2013
- 31 Jul 2013 Z-0717-2014 Class II Terminated The affected lots of the product may contain a contaminant of fungus that can cause a loss of staining sensitivity and/or obstructions to fluid delivery to the slide.
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.
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.
Information
- Country
- United Kingdom
- Address
- Balliol Business Park , Newcastle Upon Tyne, United Kingdom (ex Northern Ireland)
- Website
- www.leicabiosystems.com
- [email protected]
- PRRC contact
- Lynne Dobson
- EUDAMED SRN
- GB-MF-000020595
- FDA FEI number
- 3004859032