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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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BOND™ - 05055331328212

Muc-5AC Glycoprotein (CLH2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of Muc-5AC Glycoprotein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0052
In Commercial Distribution

  • 05055331328212 ()
PA0052

  • Mucin IVD, antibody

BOND™ - 05055331328205

Muc-1 Glycoprotein (Ma695) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of Muc-1 Glycoprotein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0051
In Commercial Distribution

  • 05055331328205 ()
PA0051

  • Mucin IVD, antibody

BOND™ - 05055331328007

c-erbB-2 Oncoprotein (CB11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of c-erbB-2 oncoprotein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0983
In Commercial Distribution

  • 05055331328007 ()
PA0983

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

BOND™ - 05055331327901

c-erbB-2 Oncoprotein (CB11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of c-erbB-2 oncoprotein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0571
In Commercial Distribution

  • 05055331327901 ()
PA0571

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

BOND™ - 05055331327000

Inhibin Alpha (R1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human inhibin alpha in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0488
In Commercial Distribution

  • 05055331327000 ()
PA0488

  • Inhibin A IVD, antibody

Novocastra™ - 05055331326850

NCL-L-CEA-609 is intended for the qualitative identification by light microscopy of carcinoembryonic antigen in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CEA-609-L-CE
In Commercial Distribution

  • 05055331326850 ()
NCL-L-CEA-609

  • Carcinoembryonic antigen (CEA) IVD, antibody

Novocastra™ - 05055331326843

NCL-L-AE1/AE3-601 is intended for the qualitative identification by light microscopy of human cytokeratins 56.5, 50, 50’, 48 and 40 kD of the acidic subfamily and 65 to 67, 64, 59, 58, 56 and 52 kD of the basic subfamily in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AE1/AE3-601-L-CE
In Commercial Distribution

  • 05055331326843 ()
NCL-L-AE1/AE3-601

  • Cytokeratin IVD, antibody

BOND™ - 05055331326836

Immunoglobulin G (RWP49) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of immunoglobulin G in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0905
In Commercial Distribution

  • 05055331326836 ()
PA0905

  • Total immunoglobulin G (IgG total) IVD, antibody

BOND™ - 05055331326829

CD15 (MMA) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD15 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0473
In Commercial Distribution

  • 05055331326829 ()
PA0473

  • CD15 cell marker IVD, antibody

BOND™ - 05055331326812

Carcinoembryonic Antigen (CD66e) (COL-1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of carcinoembryonic antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0848
In Commercial Distribution

  • 05055331326812 ()
PA0848

  • Carcinoembryonic antigen (CEA) IVD, antibody

BOND™ - 05055331326805

CD79a (JCB117) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD79a protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0599
Not in Commercial Distribution

  • 05055331326805 ()
PA0599

  • CD79a cell marker IVD, antibody

BOND - 05055331326515

p40 (BC28) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of p40 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0163
In Commercial Distribution

  • 05055331326515 ()
PA0163

  • p40 protein IVD, antibody

BOND™ - 05055331326492

Alpha-Methylacyl-CoA Racemase (EPMU1) antibody is intended to be used for the qualitative identification by light microscopy of alpha-methylacyl-CoA racemase molecules in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0210
In Commercial Distribution

  • 05055331326492 ()
PA0210

  • p504s protein IVD, antibody

BOND™ - 05055331326485

Napsin A (IP64) antibody is intended to be used for the qualitative identification by light microscopy of napsin A molecules in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0064
In Commercial Distribution

  • 05055331326485 ()
PA0064

  • Napsin A IVD, antibody

Novocastra™ - 05055331326478

NCL-L-CHROM-430 is intended for the qualitative identification by light microscopy of chromogranin A molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CHROM-430-L-CE
In Commercial Distribution

  • 05055331326478 ()
NCL-L-CHROM-430

  • Chromogranin A IVD, antibody

Novocastra™ - 05055331326461

NCL-L-CD16 is intended for the qualitative identification by light microscopy of human CD16 antigen in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD16-L-CE
In Commercial Distribution

  • 05055331326461 ()
NCL-L-CD16

  • CD16 cell marker IVD, antibody

Novocastra™ - 05055331326454

NCL-L-B-CAT is intended for the qualitative identification by light microscopy of human beta-catenin in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
B-CAT-L-CE
In Commercial Distribution

  • 05055331326454 ()
NCL-L-B-CAT

  • Beta-catenin IVD, antibody

Novocastra™ - 05055331326447

NCL-L-AFP is intended for the qualitative identification by light microscopy of human alpha fetoprotein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AFP-L-CE
In Commercial Distribution

  • 05055331326447 ()
NCL-L-AFP

  • Alpha-fetoprotein (AFP) IVD, antibody

Novocastra™ - 05055331326430

NCL-L-CD13-304 is intended for the qualitative identification by light microscopy of human CD13 antigen in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD13-304-L-CE
In Commercial Distribution

  • 05055331326430 ()
NCL-L-CD13-304

  • CD13 cell marker IVD, antibody

Novocastra™ - 05055331326423

NCL-L-CD71-309 is intended for the qualitative identification by light microscopy of human CD71 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD71-309-L-CE
In Commercial Distribution

  • 05055331326423 ()
NCL-L-CD71-309

  • CD71 cell marker IVD, antibody

Novocastra™ - 05055331326416

NCL-L-CK17 is intended for the qualitative identification by light microscopy of human cytokeratin 17 intermediate filament protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CK17-L-CE
In Commercial Distribution

  • 05055331326416 ()
NCL-L-CK17

  • Cytokeratin IVD, antibody

BOND™ - 05055331326300

Enhancer of Zeste Homolog 2 (Drosophila) (EZH2) (6A10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human EZH2 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0575
Not in Commercial Distribution

  • 05055331326300 ()
PA0575

  • Enhancer of zeste homolog 2 (EZH2) IVD, antibody

BOND™ - 05055331326201

Cyclin D1 (EP12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of cyclin D1 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0046
In Commercial Distribution

  • 05055331326201 ()
PA0046

  • Cyclin D1 IVD, antibody

BOND™ - 05055331326027

von Willebrand Factor (36B11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human von Willebrand Factor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0055
In Commercial Distribution

  • 05055331326027 ()
PA0055

  • Coagulation factor VIII-associated antigen IVD, antibody

BOND™ - 05055331326003

CD13 (38C12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD13 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0304
In Commercial Distribution

  • 05055331326003 ()
PA0304

  • CD13 cell marker IVD, antibody

BOND™ - 05055331325945

Oct-3/4 (N1NK) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of Oct-3/4 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0193
In Commercial Distribution

  • 05055331325945 ()
PA0193

  • Oct-3/4 IVD, antibody

BOND™ - 05055331325921

Muc-2 (Ccp58) antibody is intended to be used for the qualitative identification by light microscopy of Muc-2 glycoprotein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0155
In Commercial Distribution

  • 05055331325921 ()
PA0155

  • Mucin IVD, antibody

BOND™ - 05055331325907

Chromogranin A (5H7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human chromogranin A in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0515
In Commercial Distribution

  • 05055331325907 ()
PA0515

  • Chromogranin A IVD, antibody

Novocastra™ - 05055331325808

NCL-L-CD31-607 is intended for the qualitative identification by light microscopy of human CD31 (PECAM-1) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD31-607-L-CE
In Commercial Distribution

  • 05055331325808 ()
NCL-L-CD31-607

  • CD31 endothelial cell marker IVD, antibody

Novocastra™ - 05055331325785

NCL-L-CD117-032 is intended for the qualitative identification by light microscopy of human c-kit oncoprotein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD117-032-L-CE
In Commercial Distribution

  • 05055331325785 ()
NCL-L-CD117-032

  • CD117 (c-kit) cell marker IVD, antibody
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