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LEICA BIOSYSTEMS NEWCASTLE LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30048590323004859032LEICA BIOSYSTEMS NEWCASTLE LTD1N2026-01-01BALLIOL BUSINESS PARK WEST BENTON LANE NEWCASTLE UPON TYNE GB NE12 8EW

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05055331302038Novocastra™ - Novocastra™ Peroxidase Detection Systems (250 tests) RE7110-K and (500 tests) RE7120-K are for the visualization of mouse IgG, mouse IgM and rabbit IgG primary antibodies. Novocastra™ DAB (250 Slides) RE7190-K, Novocastra™ Biotinylated Secondary Antibody RE7103 and Novocastra™ Streptavidin-HRP RE7104 are component reagents of these systems that are intended for use in the procedure described below.+1(800)2480123tech.support@leicabiosystems.com
05055331304407BOND™ - Muscle Specific Actin (HHF35) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human muscle specific alpha- and gamma-actin isomers in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).+1(800)2480123tech.support@leicabiosystems.com
05055331311788Novocastra™ - NCL-L-CK20-561 is intended for the qualitative identification by light microscopy of Cytokeratin 20 molecules in paraffin sections.+1(800)2480123tech.support@leicabiosystems.com
05055331315229Novocastra™ - NCL-L-CBE-356 is intended for the qualitative identification by light microscopy of c-erbB-2 Oncoprotein molecules in paraffin sections.+1(800)2480123tech.support@leicabiosystems.com
05055331321206Novocastra™ - NCL-L-MSA is intended for the qualitative identification by light microscopy of human muscle specific alpha- and gamma-actin isomers in paraffin sections+1(800)2480123tech.support@leicabiosystems.com
05055331334725BOND™ - Muscle Specific Actin (HHF35) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human muscle specific alpha- and gamma-actin isomers in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).+1(800)2480123tech.support@leicabiosystems.com
05055331340900BOND - For in vitro diagnostic use. Nectin-4 (EPR21192-113) is intended to be used for the qualitative identification by light microscopy of human Nectin-4 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.+1(800)2480123tech.support@leicabiosystems.com
05055331340917BOND - For in vitro diagnostic use. NKX3.1 (EP356) is intended to be used for the qualitative identification by light microscopy of human NKX3.1 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.+1(800)2480123tech.support@leicabiosystems.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2070411224456456P090015BOND ORACLE HER2 IHC SYSTEMMVC2012-04-18
2070412015420733K213348BOND MMR Antibody PanelPZJ2023-02-21
2070411967535166K193393BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).MXZ2020-03-06
2070411798320837K183102BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal AntibodyMXZ2018-12-07
2070411435550809K183100Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, NovocastraMYA2018-12-07
2070411851624417K062615VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16MXZ2007-01-29
2070412064572411K060227VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)MYA2006-05-25
2070411144495608
2070411842104310
2070411871429337
2070412007948956

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MXZ32020-03-06
MYA22018-12-07
PZJ12023-02-21
MVC12012-04-18

PMN#

GUDID#

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