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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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Liquichek ANA Control, Homogeneous Pattern Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
107
In Commercial Distribution

  • 00847661000082 ()
107

  • Multiple antinuclear antibody (ANA) screening IVD, control
No Description
BIOCARE MEDICAL LLC
NPAI3170T40
In Commercial Distribution

  • 00847627040572 ()


  • CD3 cell marker IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI379T80
In Commercial Distribution

  • 00847627040510 ()


  • Paired box protein (PAX) IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI379T40
In Commercial Distribution

  • 00847627040503 ()


  • Paired box protein (PAX) IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAA3291T80
In Commercial Distribution

  • 00847627040473 ()


  • Helicobacter pylori antigen IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3299AA
In Commercial Distribution

  • 00847627035172 ()


  • Insulinoma-associated protein 1 (INSM1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3299C
In Commercial Distribution

  • 00847627035165 ()


  • Insulinoma-associated protein 1 (INSM1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3299A
In Commercial Distribution

  • 00847627035158 ()


  • Insulinoma-associated protein 1 (INSM1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
OPAI3296T60
In Commercial Distribution

  • 00847627035097 ()


  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ALI3296G7
In Commercial Distribution

  • 00847627035080 ()


  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
AVI3296G
In Commercial Distribution

  • 00847627035073 ()


  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3296AA
In Commercial Distribution

  • 00847627035066 ()


  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3296C
In Commercial Distribution

  • 00847627035059 ()


  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3296A
In Commercial Distribution

  • 00847627035042 ()


  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
PM405H
In Commercial Distribution

  • 00847627035011 ()


  • GATA protein transcription factor IVD, antibody
No Description
BIOCARE MEDICAL LLC
API438H
In Commercial Distribution

  • 00847627035004 ()


  • Paired box protein (PAX) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ALI3252H
In Commercial Distribution

  • 00847627034991 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3252C
In Commercial Distribution

  • 00847627034984 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
No Description
BIOCARE MEDICAL LLC
PM388H
In Commercial Distribution

  • 00847627034977 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
OPAI3157DS
In Commercial Distribution

  • 00847627034953 ()


  • Multiple solid tumour differentiation marker IVD, antibody
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