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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, Centromere Pattern, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
112
In Commercial Distribution

  • 00847661000112 ()
112

  • Multiple antinuclear antibody (ANA) screening IVD, control
Liquichek ANA Control, Nucleolar Pattern, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
111
In Commercial Distribution

  • 00847661000105 ()
111

  • Multiple antinuclear antibody (ANA) screening IVD, control
Liquichek ANA Control, Speckled Pattern, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
108
In Commercial Distribution

  • 00847661000099 ()
108

  • Multiple antinuclear antibody (ANA) screening IVD, control
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
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