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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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APLS IgM Control Lot Data
BIO-RAD LABORATORIES, INC.
6632040
In Commercial Distribution

  • 00847865000659 ()

  • 1 Each
6632040

  • Phospholipid IVD, control
APLS IgM Control Set
BIO-RAD LABORATORIES, INC.
6632030
In Commercial Distribution

  • 00847865000642 ()

  • 6 Vials
  • Total Volume: 1.5 Milliliter
6632030

  • Phospholipid IVD, control
APLS IgG Control Lot Data
BIO-RAD LABORATORIES, INC.
6631940
In Commercial Distribution

  • 00847865000598 ()

  • 1 Each
6631940

  • Phospholipid IVD, control
APLS IgG Control Set
BIO-RAD LABORATORIES, INC.
6631930
In Commercial Distribution

  • 00847865000581 ()

  • Total Volume: 1.5 Milliliter
  • 6 Vials
6631930

  • Phospholipid IVD, control
No Description
BIOCARE MEDICAL LLC
ACI3276A
In Commercial Distribution

  • 00847627029584 ()


  • Glucagon IVD, antibody
No Description
BIOCARE MEDICAL LLC
ALI421G7
In Commercial Distribution

  • 00847627029195 ()


  • ETS-related gene (ERG) protein IVD, antibody
No Description
OXOID LIMITED
DD0008T
In Commercial Distribution

  • 05032384034130 ()


  • Metronidazole differentiation disc IVD
NCL-DRP2 is intended for the qualitative identification by light microscopy of Utrophin (N-terminus) by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
DRP2-CE
Not in Commercial Distribution

  • 05055331310521 ()
NCL-DRP2

  • Utrophin IVD, antibody
NCL-DYS1 is intended for the qualitative identification by light microscopy of Dystrophin (Rod Domain) by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
DYS1-CE
Not in Commercial Distribution

  • 05055331310439 ()
NCL-DYS1

  • Dystrophin IVD, antibody
NCL-DYS2 is intended for the qualitative identification by light microscopy of Dystrophin (C-terminus) by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
DYS2-CE
Not in Commercial Distribution

  • 05055331310392 ()
NCL-DYS2

  • Dystrophin IVD, antibody
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