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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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Multi-Cytokeratin (AE1/AE3) antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratins in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0909-U
In Commercial Distribution

  • 05055331335500 ()
PA0909-U

  • Cytokeratin IVD, antibody
Cytokeratin 8 (TS1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 8 intermediate filament protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0567-U
In Commercial Distribution

  • 05055331335289 ()
PA0567-U

  • Cytokeratin IVD, antibody
Cytokeratin 5 (XM26) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0468-U
In Commercial Distribution

  • 05055331335142 ()
PA0468-U

  • Cytokeratin IVD, antibody
Cytokeratin 7 (RN7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 7 intermediate filament protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0138-U
In Commercial Distribution

  • 05055331334473 ()
PA0138-U

  • Cytokeratin IVD, antibody
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 BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0134-U
In Commercial Distribution

  • 05055331334466 ()
PA0134-U

  • Cytokeratin IVD, antibody
Cytokeratin 17 (E3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 17 (CK17) intermediate filament protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0114-U
In Commercial Distribution

  • 05055331334404 ()
PA0114-U

  • Cytokeratin IVD, antibody
Cytokeratin (AE1/AE3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratins 40, 48, 50 and 56.5 kD of the acidic subfamily and 52, 56, 58, 59, 64 and 65 to 67 kD of the basic subfamily in formalin fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0094-U
In Commercial Distribution

  • 05055331334381 ()
PA0094-U

  • Cytokeratin IVD, antibody
Cytokeratin 20 (Ks20.8) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 20 intermediate filament protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0037-U
In Commercial Distribution

  • 05055331334206 ()
PA0037-U

  • Cytokeratin IVD, antibody
Cytokeratin 20 (Ks20.8) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 20 intermediate filament protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0022-U
In Commercial Distribution

  • 05055331334145 ()
PA0022-U

  • Cytokeratin IVD, antibody
NCL-L-LL002-U is intended for the qualitative identification by light microscopy of Cytokeratin 14 molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
LL002-L-U
In Commercial Distribution

  • 05055331333933 ()
NCL-L-LL002-U

  • Cytokeratin IVD, antibody
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