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Leica Biosystems Newcastle, Limited

Active in EUDAMED

Registered as Leica Biosystems Newcastle Ltd in EUDAMED

Also registered as Leica Biosystems Newcastle Ltd

United Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000020595 FEI 3004859032

Devices
959
Registrations
EUDAMEDFDA
FDA recalls
1

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue959

Newest first, rows 901-950 of 959

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  • BCL6 (3q27) Proximal - XL Ref KBI-XL009

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • MDM2 (12q15) - XL Ref KBI-XL014

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Leica HER2 FISH Control Slides Ref TA9123

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • BCL6 (3q27) Break (tissue) Ref KBI-10730

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Novocastra Polymer Detection System (250 tests) Ref RE7140-K

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-CD19-163

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • BOND Polymer Refine Red Detection Ref DS9390

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-End

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-CD38-290

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-CD71-309

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-Synap-299

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • BCL2 (18q21) Break (tissue) Ref KBI-10745

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • DDIT3 (12q13 Break Ref KBI-10714

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Novolink Polymer Ref RE7200-K

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-CD20-L26

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-CK7-560

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-CD8-4B11

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-CD4-368

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • MDM2 (12q15)/SE 12 Ref KBI-10717

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Ncl-L-Cea-609

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • BOND-PRIME Epitope Retrieval Solution 2 Ref AR0087

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-DYS2

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • NCL-d-SARC

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-MLH1

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-DYS3

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Novocastra Peroxidase Detection System (250 tests) Ref RE7110-K

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • NCL-L-a-SARC

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-Tpo

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • BOND Epitope Retrieval Solution 2 Ref AR9640

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • NCL-L-CD1a-235

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-Plap-8A9

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-Lam-578

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Anti-Fluorescein Antibody Ref AR0833

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • BOND-PRIME Hematoxylin Ref AR0096

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-Caix

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Stringency Wash Solution Ref AR0633

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • NCL-L-MelanA

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • BCL2 (18q21) Distal - XL Ref KBI-XL008

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Ncl-Merosin

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-CD21-2G9

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • BOND FISH Kit Ref DS9636

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-CK20

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-Cyclin D1-Gm Ref NCL-L-CYCLIND1-GM

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-Lca

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-WT1-562

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • ALK (2p23) Break Ref KBI-10747

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Ncl-L-CD123

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-OCT3/4

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-CD68

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • BOND-PRIME Dewax Solution Ref AR0084

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

Rows 901-950 of 959

Showing 901-950 of 959

Company details

EUDAMED SRN
GB-MF-000020595
FDA FEI number
3004859032
EU VAT number
GB 974 9710 70
EUDAMED status
Active
EUDAMED registered name
Leica Biosystems Newcastle Ltd
Registered address
Balliol Business Park, NE12 8EW, Newcastle Upon Tyne, United Kingdom (ex Northern Ireland)
PRRC contact
Lynne Dobson(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredIVDR 1next expiry 7 Jun 2031

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • IVDR 739320 Active Reissued

    Quality management system EU IVDR

    Issued
    1 Jun 2026
    Expires
    7 Jun 2031
    Valid from
    8 Jun 2026

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by Leica Biosystems Newcastle, Limited, initiated on 2013-07-31. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 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. Distribution: Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI,…
      Full distribution text Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and WV); and Internationally to Chile, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Sweden, Switzerland, Poland, Romania, Singapore, South Korea, and the United Kingdom.

Frequently asked questions

How many devices does Leica Biosystems Newcastle, Limited have in the registry?

The registry currently lists 959 devices for Leica Biosystems Newcastle, Limited. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for Leica Biosystems Newcastle, Limited?

FDA recall records list 1 recall initiated by Leica Biosystems Newcastle, Limited, the most recent initiated on 31 Jul 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Leica Biosystems Newcastle, Limited?

EUDAMED lists 1 certificate for Leica Biosystems Newcastle, Limited (quality management system) under IVDR. The most recent was issued on 1 Jun 2026.

Generated automatically from registry data and not verified by a human reviewer.