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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™ - 05055331304407

Muscle Specific Actin (HHF35) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human muscle specific alpha- and gamma-actin isomers 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
PA0258
In Commercial Distribution

  • 05055331304407 ()
PA0258

  • Muscle-specific alpha/gamma actin IVD, antibody

BOND™ - 05055331304391

CD7 (LP15) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD7 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
PA0266
In Commercial Distribution

  • 05055331304391 ()
PA0266

  • CD7 cell marker IVD, antibody

BOND™ - 05055331304384

CD10 (56C6) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of the human CD10 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
PA0270
In Commercial Distribution

  • 05055331304384 ()
PA0270

  • CD10 cell marker IVD, antibody

BOND™ - 05055331304377

CD2 (11F11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD2 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
PA0271
In Commercial Distribution

  • 05055331304377 ()
PA0271

  • CD2 T-cell marker IVD, antibody

BOND™ - 05055331304360

CD68 (514H12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD68 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
PA0273
In Commercial Distribution

  • 05055331304360 ()
PA0273

  • CD68 cell marker IVD, antibody

BOND™ - 05055331304353

Protein Gene Product 9.5 (10A1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human protein gene product 9.5 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
PA0286
In Commercial Distribution

  • 05055331304353 ()
PA0286

  • Protein gene product 9.5 (PGP9.5) IVD, antibody

BOND™ - 05055331304346

Granzyme B (11F1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human granzyme B. 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
PA0291
In Commercial Distribution

  • 05055331304346 ()
PA0291

  • Granzyme B IVD, antibody

BOND™ - 05055331304339

Synaptophysin (27G12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human synaptophysin 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
PA0299
In Commercial Distribution

  • 05055331304339 ()
PA0299

  • Synaptophysin IVD, antibody

BOND™ - 05055331304322

CD25 (4C9) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human interleukin-2 receptor (CD25) 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
PA0305
In Commercial Distribution

  • 05055331304322 ()
PA0305

  • CD25 cell marker IVD, antibody

BOND™ - 05055331304315

Anaplastic Lymphoma Kinase (5A4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human p80 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
PA0306
In Commercial Distribution

  • 05055331304315 ()
PA0306

  • Anaplastic lymphoma kinase IVD, antibody
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