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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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Novocastra - 05055331333179

NCL-L-AR-318-U is intended for the qualitative identification by light microscopy of androgen receptor protein in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AR-318-L-U
In Commercial Distribution

  • 05055331333179 ()
NCL-L-AR-318-U

  • Androgen receptor IVD, antibody

Novocastra - 05055331333124

NCL-L-AMACR-U is intended for the qualitative identification by light microscopy of alpha-methylacyl-CoA racemase (AMACR) molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AMACR-L-U
In Commercial Distribution

  • 05055331333124 ()
NCL-L-AMACR-U

  • p504s protein IVD, antibody

Novocastra - 05055331333117

NCL-L-ALK-U is intended for the qualitative identification by light microscopy of human p80 protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
ALK-L-H-U
In Commercial Distribution

  • 05055331333117 ()
NCL-L-ALK-U

  • Anaplastic lymphoma kinase IVD, antibody

Novocastra - 05055331333100

NCL-L-AE1/AE3-601-U 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 parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AE1/AE3-601-L-U
In Commercial Distribution

  • 05055331333100 ()
NCL-L-AE1/AE3-601-U

  • Cytokeratin IVD, antibody

Novocastra - 05055331333001

NCL-L-5D3-U is intended for the qualitative identification by light microscopy of Cytokeratin (8/18) molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
5D3-L-U
In Commercial Distribution

  • 05055331333001 ()
NCL-L-5D3-U

  • Cytokeratin IVD, antibody

BOND - 05055331331229

PD-1 (CAL20) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of PD-1 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
PA0216
In Commercial Distribution

  • 05055331331229 ()
PA0216

  • Programmed death-1 (PD-1) IVD, antibody

BOND - 05055331331205

LAG-3 (12H6) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of LAG-3 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
PA0300
In Commercial Distribution

  • 05055331331205 ()
PA0300

  • CD223 cell marker IVD, antibody

BOND - 05055331331199

CTLA-4 (CAL49) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of CTLA-4 protein in formalin-fixed, pataffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0181
In Commercial Distribution

  • 05055331331199 ()
PA0181

  • CD152 cell marker IVD, antibody

BOND - 05055331331182

FOXP3 (236A/E7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of FOXP3 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
PA0263
In Commercial Distribution

  • 05055331331182 ()
PA0263

  • Forkhead box protein (FOX) IVD, antibody

BOND - 05055331331175

TIM-3 (EPR22241) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of TIM-3 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
PA0360
In Commercial Distribution

  • 05055331331175 ()
PA0360

  • T-cell immunoglobulin and mucin domain-containing protein 3 (TIM-3) IVD, antibody

BOND - 05055331331151

Muc-4 Glycoprotein (EPR9308) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of Muc-4 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
PA0444
In Commercial Distribution

  • 05055331331151 ()
PA0444

  • Mucin IVD, antibody

BOND-PRIME - 05055331330550

BOND-PRIME Hematoxylin is a ready to use reagent that facilitates cell nuclei (blue) counterstaining of formalin-fixed, paraffinembedded tissue in immunohistochemistry (IHC) and in situ hybridization (ISH) using the automated BOND-PRIME staining system
LEICA BIOSYSTEMS NEWCASTLE LTD
AR0096
In Commercial Distribution

  • 05055331330550 ()
AR0096

  • Differentiation solution IVD

BOND - 05055331329714

S-100 (EP32) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of S-100B 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
PA0031
In Commercial Distribution

  • 05055331329714 ()
PA0031

  • S100-beta (S100-B) protein IVD, antibody

Novocastra - 05055331329707

NCL-L-S100-167 is intended for the qualitative identification by light microscopy of S-100B protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
S100-167-L-CE
In Commercial Distribution

  • 05055331329707 ()
NCL-L-S100-167

  • S100-beta (S100-B) protein IVD, antibody

BOND™ - 05055331329684

p16 (6H12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human p16 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
PA0016
In Commercial Distribution

  • 05055331329684 ()
PA0016

  • p16 antigen IVD, antibody

BOND™ - 05055331328908

Programmed Death Ligand 1 (73-10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of endogenous PD-L1 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
PA0832
In Commercial Distribution

  • 05055331328908 ()
PA0832

  • Programmed death-ligand 1 (PD-L1) IVD, antibody

BOND™ - 05055331328847

MLH1 (Mismatch Repair Protein) (ES05) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of MLH1 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
PA0988
Not in Commercial Distribution

  • 05055331328847 ()
PA0988

  • MLH1 antigen IVD, antibody

BOND - 05055331328830

MSH2 (Mismatch Repair Protein) (79H11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of MSH2 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
PA0989
Not in Commercial Distribution

  • 05055331328830 ()
PA0989

  • MSH2 antigen IVD, antibody

BOND - 05055331328823

PMS2 (Mismatch Repair Protein) (EP51) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of PMS2 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
PA0991
Not in Commercial Distribution

  • 05055331328823 ()
PA0991

  • Postmeiotic segregation increased 2 (PMS2) IVD, antibody

BOND - 05055331328816

MSH6 (Mismatch Repair Protein) (EP49) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of MSH6 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
PA0990
Not in Commercial Distribution

  • 05055331328816 ()
PA0990

  • MSH6 antigen IVD, antibody

Novocastra™ - 05055331328809

NCL-L-MSH2-612 is intended for the qualitative identification by light microscopy of Mismatch Repair Protein 2 (MSH2) in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
MSH2-612-L-CE
In Commercial Distribution

  • 05055331328809 ()
NCL-L-MSH2-612

  • MSH2 antigen IVD, antibody

BOND™ - 05055331328700

Anaplastic Lymphoma Kinase (5A4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of endogenous ALK and ALK fusion proteins 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
PA0831
In Commercial Distribution

  • 05055331328700 ()
PA0831

  • Anaplastic lymphoma kinase IVD, antibody

Novocastra™ - 05055331328410

NCL-L-HHV8-LNA is intended for the qualitative identification by light microscopy of Human Herpesvirus (Type 8) (latent nuclear antigen) in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
HHV8-LNA-CE
In Commercial Distribution

  • 05055331328410 ()
NCL-HHV8-LNA

  • Human herpesvirus 8 (HHV8) antigen IVD, antibody

Novocastra™ - 05055331328403

NCL-L-AR-318 is intended for the qualitative identification by light microscopy of androgen receptor protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AR-318-L-CE
In Commercial Distribution

  • 05055331328403 ()
NCL-L-AR-318

  • Androgen receptor IVD, antibody

BOND™ - 05055331328335

Cytokeratin (AE1/AE3) monoclonal antibody is intended to be used 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 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
PA0094
In Commercial Distribution

  • 05055331328335 ()
PA0094

  • Cytokeratin IVD, antibody

BOND™ - 05055331328311

Human Herpesvirus (Type 8) (13B10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human herpesvirus (Type 8) (latent nuclear 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
PA0050
In Commercial Distribution

  • 05055331328311 ()
PA0050

  • Human herpesvirus 8 (HHV8) antigen IVD, antibody

BOND™ - 05055331328304

Muc-6 Glycoprotein (CLH5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of Muc-6 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
PA0053
In Commercial Distribution

  • 05055331328304 ()
PA0053

  • Mucin IVD, antibody

Novocastra™ - 05055331328243

NCL-L-PTH-488 is intended for the qualitative identification by light microscopy of human parathyroid hormone in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
PTH-488-L-CE
In Commercial Distribution

  • 05055331328243 ()
NCL-L-PTH-488

  • Parathyroid hormone (PTH) IVD, antibody

Novocastra™ - 05055331328236

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

  • 05055331328236 ()
NCL-L-LANGERIN

  • CD207 cell marker IVD, antibody

Novocastra™ - 05055331328229

NCL-L-p57 is intended for the qualitative identification by light microscopy of human p57protein, also known as Kip2 protein, in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
P57-L-CE
In Commercial Distribution

  • 05055331328229 ()
NCL-L-p57

  • P57 protein IVD, antibody

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
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