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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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No Description
RANDOX LABORATORIES LIMITED
AL8304
In Commercial Distribution

  • 05055273208160 ()


  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AL8006
In Commercial Distribution

  • 05055273208153 ()


  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
For the quantitative in vitro determination of Ammonia in plasma.
RANDOX LABORATORIES LIMITED
AM3979
In Commercial Distribution

  • 05055273200270 ()
AM3979

  • Ammonia IVD, kit, enzyme spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AM1054
In Commercial Distribution

  • 05055273200263 ()
AM1054

  • Ammonia IVD, kit, enzyme spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AM1015
In Commercial Distribution

  • 05055273200256 ()
AM1015

  • Ammonia IVD, kit, enzyme spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AL7930
In Commercial Distribution

  • 05055273200249 ()
AL7930

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AL7904
In Commercial Distribution

  • 05055273200232 ()
AL7904

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human HMB45 antigen 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
PA0625-U
In Commercial Distribution

  • 05055331335333 ()
PA0625-U

  • Melanoma specific protein IVD, antibody
Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human HMB45 antigen 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
PA0027-U
In Commercial Distribution

  • 05055331334169 ()
PA0027-U

  • Melanoma specific protein IVD, antibody
NCL-L-HMB45-U is intended for the qualitative identification by light microscopy of human HMB45 antigen in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
HMB45-L-U
In Commercial Distribution

  • 05055331333827 ()
NCL-L-HMB45-U

  • Melanoma specific protein IVD, antibody
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