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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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Calibration of Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873686
In Commercial Distribution

  • 00630414287430 ()
  • 00630414285009 ()
OQCV07

  • Lipoprotein A IVD, calibrator
Assayed control for Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873687
In Commercial Distribution

  • 00630414287447 ()
  • 00630414285016 ()
OQCW07

  • Lipoprotein A IVD, control
NCL-L-InhibinA is intended for the qualitative identification by light microscopy of inhibin alpha molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
INHIBINA-L-CE
In Commercial Distribution

  • 05055331318350 ()
NCL-L-InhibinA

  • Inhibin A IVD, antibody
NCL-L-Napsin A is intended for the qualitative identification by light microscopy of Napsin A molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
NAPSINA-L-CE
In Commercial Distribution

  • 05055331305572 ()
NCL-L-Napsin A

  • Napsin A IVD, antibody
Chromogranin A (5H7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human chromogranin A 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
PA0430
In Commercial Distribution

  • 05055331304124 ()
PA0430

  • Chromogranin A IVD, antibody
Randox Lipoprotein(a) level 3 control is based on lyophilised human serum containing Lipoprotein(a).
RANDOX LABORATORIES LIMITED
LP3406
In Commercial Distribution

  • 05055273204445 ()


  • Lipoprotein A IVD, control
This product is intended for use in the calibration of Lipoprotein(a) assays.
RANDOX LABORATORIES LIMITED
LP3404
In Commercial Distribution

  • 05055273204438 ()
LP3404

  • Lipoprotein A IVD, calibrator
Chromogranin A (5H7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human chromogranin A 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
PA0515-U
In Commercial Distribution

  • 05055331335197 ()
PA0515-U

  • Chromogranin A IVD, antibody
Inhibin Alpha (R1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human inhibin alpha 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
PA0488-U
In Commercial Distribution

  • 05055331335166 ()
PA0448-U

  • Inhibin A IVD, antibody
NCL-L-NapsinA-U is intended for the qualitative identification by light microscopy of Napsin A molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
NAPSINA-L-U
In Commercial Distribution

  • 05055331334039 ()
NCL-L-NAPSINA-U

  • Napsin A IVD, antibody
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