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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-MLH1 Mouse Monoclonal Antibody [GM011], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8324-C010
In Commercial Distribution

  • 00615233001580 ()
8324-C010

  • MLH1 antigen IVD, antibody
anti-MLH1 Mouse Monoclonal Antibody [GM011], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8324-M250
In Commercial Distribution

  • 00615233001573 ()
8324-M250

  • MLH1 antigen IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3079G3
In Commercial Distribution

  • 00847627004116 ()


  • p40 protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3066H
In Commercial Distribution

  • 00847627004079 ()


  • p40 protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3066AA
In Commercial Distribution

  • 00847627004062 ()


  • p40 protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3045AA
In Commercial Distribution

  • 00847627004017 ()


  • Topoisomerase IIa IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3043AA
In Commercial Distribution

  • 00847627004000 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3174B
In Commercial Distribution

  • 00847627003454 ()


  • Galectin-3 IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3174A
In Commercial Distribution

  • 00847627003447 ()


  • Galectin-3 IVD, antibody
No Description
BIOCARE MEDICAL LLC
IP107G10
In Commercial Distribution

  • 00847627008619 ()


  • Epithelial antigen IVD, antibody
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