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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 851-900 of 959

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  • Ncl-SPEC1

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

  • Ncl-L-CD2-271

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

  • Epitope Retrieval Solution (x10 Concentrate) pH9 Ref RE7119

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • ROS1 (6q22) Break Ref KBI-10752

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

  • NCL-L-FRalpha

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

  • Ncl-L-Er-6F11/2

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

  • Ncl-L-AE1/AE3-601

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

  • MET (7q31) - XL Ref KBI-XL003

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

  • BOND-PRIME Wash Solution Concentrate Ref AR0085

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Novocastra Enzyme Proteinase K (IHC) Ref RE7160-K

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • BOND Primary Antibody Diluent Ref AR9352

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • FOXO1 (13q14) Break Ref KBI-10716

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

  • Ncl-L-S100-167

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

  • Ncl-L-Ar-318

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

  • Leica HER2 FISH System - 30 Test Ref TA9217

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

  • NCL-L-bcl-2

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

  • ESWR1 (22q12) Proximal - XL Ref KBI-XL019

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

  • Ncl-DRP2

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

  • FISH Digestion Kit Ref KBI-60006

    Active Regimes: CE IVDR Registry: EUDAMED Class:A

  • Ncl-L-CD30-591

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

  • BOND Polymer Refine Detection Ref DS9800

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Novocastra Protein Block Ref RE7102

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • BOND Enzyme Pretreatment Kit Ref AR9551

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • NCL-L-Hpylori

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

  • Negative (Rabbit) 7mL Ref PA0777

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:B

  • NCL-L-p57

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

  • NCL-L-E-Cad

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

  • Novocastra Streptavidin-HRP Ref RE7104

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-Kap-581

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

  • Ncl-L-Vim-V9

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

  • DDIT3 (12q13) Proximal - XL Ref KBI-XL015

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

  • BOND RNAScope Brown Detection Ref DS9815

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-Er-6F11

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

  • Ncl-L-MSH2-612

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

  • Ncl-L-Alk

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

  • Bond Open Container 30 mL Ref OP309700

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-CD10-270

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

  • Ncl-L-Calcitonin

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

  • Epitope Retrieval Solution (x10 Concentrate) pH8 Ref RE7116

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • CCND1 (11q13) Proximal - XL Ref KBI-XL013

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

  • BOND Titration Container 6 mL Ref OPT9049

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-HMB45

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

  • Ncl-L-Calret-566

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

  • Se 17 (D17Z1) - Xl Ref KBI-XL020

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

  • Ncl-Hamlet-2

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

  • ChromoPlex 1 Dual Detection Ref DS9477

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • NCL-L-vWF

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

  • ALK (2p23) Proximal - XL Ref KBI-XL001

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

  • Ncl-L-CD7-580

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

  • Ncl-L-Meso

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

Rows 851-900 of 959

Showing 851-900 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.