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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 801-850 of 959

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  • NCL-L-IgA

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

  • Epitope Retrieval Solution (x10 Concentrate) pH6 Ref RE7113

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-MSH6

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

  • BOND Dewax Solution Ref AR9222

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • NCL-L-IgM

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

  • Anti-Biotin Antibody Ref AR0584

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-Pax-5

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

  • BOND Wash Solution 10X Concentrate Ref AR9590

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • MAF (16q23)/D16Z3 Ref KBI-00116

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

  • NCL-L-b-SARC

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

  • Ncl-Emerin

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

  • Ncl-L-Dog-1

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

  • NCL-L-IgD

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

  • NCL-b-DG

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

  • Ncl-L-CK5

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

  • EWSR1 (22q12) Break Ref KBI-10750

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

  • Ncl-L-Amacr

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

  • MAX DAB (Polymer) 1250 tests) Ref RE7270-K

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-MUM1

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

  • NCL-L-Myf-4

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

  • Ncl-L-Ttf-1

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

  • Ncl-L-CK7-Ovtl

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

  • Ncl-L-Pgr-312

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

  • NCL-L-p63

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

  • NCL-L-Ki67-MM1

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

  • FUS (16p11) Break Ref KBI-10715

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

  • Ncl-L-CD5-4C7

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

  • Novolink Min Polymer Detection System (50 tests) Ref RE7290-K

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Novocastra Peroxidase Block Ref RE7101

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Novolink DAB (Polymer) 250 tests Ref RE7230-K

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-Egfr

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

  • FOXO1 (13q14) Distal - XL Ref KBI-XL016

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

  • Ncl-L-Gfap-GA5

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

  • Epithelial Membrane Antigen GP1.4 7 mL Ref PA0035

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:C

  • Ncl-L-Afp

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

  • BOND-PRIME Polymer DAB Detection System Ref DS9284

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-B-Cat

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

  • Ncl-L-Sma

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

  • SS18 (18q11) Break Ref KBI-10713

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

  • MET (7q31)/SE 7 Ref KBI-10719

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

  • Ncl-L-5D3

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

  • Chromoplex 1 Dual Detection - 50 Test Ref DS9665

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Anti-Fluorescein Antibody Ref AR0222

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-Tdt-339

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

  • MYC (8q24) Distal - XL Ref KBI-XL006

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

  • Novolink Polymer Detection System (500 tests) Ref RE7150-K

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • BOND Epitope Retrieval Solution 1 Ref AR9961

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-Msa-594

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

  • Ncl-L-Pth-488

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

  • Ncl-L-CD15-605

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

Rows 801-850 of 959

Showing 801-850 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.