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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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anti-BCL2 Rabbit Monoclonal Antibody [EP36], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8459-M250
In Commercial Distribution

  • 00615233002129 ()
8459-M250

  • Bcl-2 oncoprotein IVD, antibody
anti-S100B Rabbit Monoclonal Antibody [EP32], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8442-M250
In Commercial Distribution

  • 00615233002075 ()
8442-M250

  • S100 protein IVD, antibody
anti-S100B Rabbit Monoclonal Antibody [EP32], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8442-C010
In Commercial Distribution

  • 00615233002068 ()
8442-C010

  • S100 protein IVD, antibody
anti-Napsin A Rabbit Monoclonal Antibody [EP205], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8331-C010
In Commercial Distribution

  • 00615233001696 ()
8331-C010

  • Napsin A IVD, antibody
anti-Napsin A Rabbit Monoclonal Antibody [EP205], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8331-M250
In Commercial Distribution

  • 00615233001689 ()
8331-M250

  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3215AA
In Commercial Distribution

  • 00847627004833 ()


  • MSH6 antigen IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3214AA
In Commercial Distribution

  • 00847627004826 ()


  • MLH1 antigen IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3202AA
In Commercial Distribution

  • 00847627004765 ()


  • Granzyme B IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3174AA
In Commercial Distribution

  • 00847627004598 ()


  • Galectin-3 IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3156H
In Commercial Distribution

  • 00847627004420 ()


  • Ki67 antigen IVD, antibody
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