FDA.reportPublic FDA data

Leica Biosystems Richmond, Inc.

Matched from indexed company URL: Leica Biosystems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14193411419341Leica Biosystems Richmond, Inc.1N2026-01-015205 Us Highway 12 Richmond IL US 60071
80104783002179321LEICA BIOSYSTEMS NUSSLOCH GMBH1N2026-01-01HEIDELBERGER STR. 17-19 NUSSLOCH Baden-Wurttemberg DE 69222
30048590323004859032LEICA BIOSYSTEMS NEWCASTLE LTD1N2026-01-01BALLIOL BUSINESS PARK WEST BENTON LANE NEWCASTLE UPON TYNE GB NE12 8EW
30067913733006791373Leica Biosystems Imaging, Inc.1N2026-01-011360 Park Center Drive Vista CA US 92081
30224463993022446399LEICA BIOSYSTEMS, DIVISION OF LEICA MICROSYSTEMS, INC.1Y2026-01-0121440 W. Lake Cook Road Floor 5 Deer Park IL US 60010

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
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
08718858480043Kreatech FISH probes - 10Q002B550+(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
2185701785353287K252762HALO AP DxQKQ2025-11-25
2185701884352706K232202Aperio GT 450 DXPSY2024-04-16
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
2185702045257946K190332Aperio AT2 DX SystemPSY2019-05-20
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
2185701633430479K141109APERIO EPATHOLOGY EIHC IVD SYSTEMNOT2014-07-29
2070411851624417K062615VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16MXZ2007-01-29
2070412064572411K060227VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)MYA2006-05-25
2090821099788577K042542CYTOVISION FOR CEP XYNTH2005-01-10
2090821461086652K033200ARIOLNQN2004-03-18
2090821794327664
2090821998795121
2090821013888113
2090821030888188
2090821035972339
2090821054010166
2185701115714395
2071481120308909
2090821138894501
2071481144495608
2070411144495608
2090821195990981
2071481195990981
2090821202225597
2090821222435582
2090821243875914
2090821273936800
2090821279653654
2090821286617776
2090821304060555
2090821305066030
2090821390128368
2071481403731565
2090821405325470
2090821442496220
2071481504718450
2090821509737917
2090821524072887
2090821553325393
2090821575709001
2090821609385462
2090821672802367
2090821712092241
2071481726147003
2071481746109495
2090821764693502
2090821776446692
2070411842104310
2090821842104310
2070411871429337
2071481899098514
2090821937477318
2090821987168400
2090821993259693
2070412007948956
2071482073418209

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MXZ32020-03-06
PSY22024-04-16
MYA22018-12-07
QKQ12025-11-25
PZJ12023-02-21
NOT12014-07-29
MVC12012-04-18
NTH12005-01-10
NQN12004-03-18

PMA#

PMN#

GUDID#

BOND - 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.

LEICA BIOSYSTEMS NEWCASTLE LTD

2026-04-10

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