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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
05055331316967Novocastra™ - NCL-L-AE1/AE3 is intended for the qualitative identification by light microscopy of cytokeratin molecules in paraffin sections.+1(800)2480123tech.support@leicabiosystems.com
05055331330581BOND-PRIME - For in vitro diagnostic use. BOND-PRIME Cleaning Kit is an accessory product specifically intended to periodically clean the BOND-PRIME ARC (Active Reagent Control) Array consisting of 24 ARC Modules and aspirating probe, using the cleaning protocol installed in BOND-PRIME. The kit consists of containers with cleaning reagents that supports maintenance of the BOND-PRIME system. This kit does not produce visualization of staining for interpretation by a qualified pathologist.+1(800)2480123tech.support@leicabiosystems.com
05055331339607BOND - For in vitro diagnostic use.BOND Ready-to-Use Primary Antibody PD-L1 (CAL10) is intended to be used for the qualitative identification by light microscopy of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) tissue by immunohistochemical staining. BOND Ready-to-Use Primary Antibody PD-L1 (CAL10) is optimized for use on the BOND-III fully automated system with BOND Polymer Refi ne Detection (DS9800) and BOND DAB Enhancer (AR9432).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
08718858480791Kreatech FISH probes - 22Q003B495+(31)206919181CustomerService.Amsterdam@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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