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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
anti-Perforin Mouse Monoclonal Antibody [5B10], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8236-M250
In Commercial Distribution

  • 00615233008503 ()
8236-M250

  • Perforin IVD, antibody
anti-Perforin Mouse Monoclonal Antibody [5B10], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8236-C010
In Commercial Distribution

  • 00615233008497 ()
8236-C010

  • Perforin IVD, antibody
No Description
BIOCARE MEDICAL LLC
ALI057G7
In Commercial Distribution

  • 00847627034007 ()


  • Melanosome IVD, antibody
No Description
BIOCARE MEDICAL LLC
ALI371G7
In Commercial Distribution

  • 00847627033918 ()


  • Synaptophysin IVD, antibody
No Description
BIOCARE MEDICAL LLC
OPAI057T60
In Commercial Distribution

  • 00847627031761 ()


  • Melanosome IVD, antibody
anti-beta-Catenin Rabbit Monoclonal Antibody [EP35], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8261-C010
In Commercial Distribution

  • 00615233000743 ()
8261-C010

  • Beta-catenin IVD, antibody
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