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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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Genemed® - 00615233011190

anti-PRAME Rabbit Monoclonal Antibody [QR005], Ready-To-Use, 15 mL
SAKURA FINETEK U.S.A., INC.
60-0185-15
In Commercial Distribution

  • 00615233011190 ()
60-0185-15

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Genemed® - 00615233011183

anti-PRAME Rabbit Monoclonal Antibody [QR005], Concentrate, 1 mL
SAKURA FINETEK U.S.A., INC.
61-0185
In Commercial Distribution

  • 00615233011183 ()
61-0185

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Genemed® - 00615233009890

anti-PRAME Rabbit Monoclonal Antibody [EP461], Ready-To-Use, 7 mL
SAKURA FINETEK U.S.A., INC.
60-0193-7
In Commercial Distribution

  • 00615233009890 ()
60-0193-7

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Genemed® - 00615233009883

anti-PRAME Rabbit Monoclonal Antibody [EP461], Concentrate, 1 mL
SAKURA FINETEK U.S.A., INC.
61-0193
In Commercial Distribution

  • 00615233009883 ()
61-0193

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

PRAME [EPR20330] - 00847627027566

No Description
BIOCARE MEDICAL LLC
ALI3252G7
In Commercial Distribution

  • 00847627027566 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

PRAME [EPR20330] - 00847627027559

No Description
BIOCARE MEDICAL LLC
OPAI3252T60
In Commercial Distribution

  • 00847627027559 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

PRAME [EPR20330] - 00847627025067

No Description
BIOCARE MEDICAL LLC
AVI3252G
In Commercial Distribution

  • 00847627025067 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

PRAME [EPR20330] - 00847627025050

No Description
BIOCARE MEDICAL LLC
API3252AA
In Commercial Distribution

  • 00847627025050 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

PRAME [EPR20330] - 00847627025043

No Description
BIOCARE MEDICAL LLC
ACI3252A
In Commercial Distribution

  • 00847627025043 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

PRAME [EPR20330] - 00847627034991

No Description
BIOCARE MEDICAL LLC
ALI3252H
In Commercial Distribution

  • 00847627034991 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
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