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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™ - 05055331304612

Bcl-2 (bcl-2/100/D5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Bcl-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
PA0117
In Commercial Distribution

  • 05055331304612 ()
PA0117

  • Bcl-2 oncoprotein IVD, antibody

BOND™ - 05055331304605

Ki67 (MM1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Ki67 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
PA0118
In Commercial Distribution

  • 05055331304605 ()
PA0118

  • Ki67 antigen IVD, antibody

BOND™ - 05055331304599

Cytokeratin HMW (34BE12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratins 1, 5, 10 and 14 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
PA0134
In Commercial Distribution

  • 05055331304599 ()
PA0134

  • Cytokeratin IVD, antibody

BOND™ - 05055331304582

CD45RO (UCHL1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD45RO 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
PA0146
In Commercial Distribution

  • 05055331304582 ()
PA0146

  • CD45RO cell marker IVD, antibody

BOND™ - 05055331304575

Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods.
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0151
In Commercial Distribution

  • 05055331304575 ()
PA0151

  • Estrogen (oestrogen)/progesterone receptor IVD, antibody

BOND™ - 05055331304551

Placental Alkaline Phosphatase (8A9) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human placental alkaline phosphatase (PLAP) 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
PA0161
In Commercial Distribution

  • 05055331304551 ()
PA0161

  • Human placental alkaline phosphatase (hPLAP) IVD, antibody

BOND™ - 05055331304544

CD5 (4C7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD5 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
PA0168
In Commercial Distribution

  • 05055331304544 ()
PA0168

  • CD5 cell marker IVD, antibody

BOND™ - 05055331304537

CD23 (1B12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD23 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
PA0169
In Commercial Distribution

  • 05055331304537 ()
PA0169

  • CD23 cell marker IVD, antibody

BOND™ - 05055331304520

CD21 (2G9) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD21 molecule 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
PA0171
In Commercial Distribution

  • 05055331304520 ()
PA0171

  • CD21 cell marker IVD, antibody

BOND™ - 05055331304513

CD8 (4B11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD8 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
PA0183
In Commercial Distribution

  • 05055331304513 ()
PA0183

  • CD8 cell marker IVD, antibody
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