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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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Lyphochek Urine Metals Control Level 1 (A human urine assayed metals control.)
BIO-RAD LABORATORIES, INC.
400
In Commercial Distribution

  • 00847661000280 ()
400

  • Multiple heavy metal IVD, control
Liquichek Autoimmune Negative Control (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
130
In Commercial Distribution

  • 00847661000228 ()
130

  • Multiple antinuclear antibody (ANA) screening IVD, control
Liquichek ANA Controls Set, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
131
In Commercial Distribution

  • 00847661000211 ()
131

  • Multiple antinuclear antibody (ANA) screening IVD, control
Liquichek Anti-Smooth Muscle Control, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
129
In Commercial Distribution

  • 00847661000204 ()
129

  • Multiple antinuclear antibody (ANA) screening IVD, control
Liquichek Anti-Mitochondrial Control, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
127
In Commercial Distribution

  • 00847661000198 ()
127

  • Mitochondrial antibody M2 (anti-Mi2) IVD, control
No Description
BIOCARE MEDICAL LLC
NPAA3291T40
In Commercial Distribution

  • 00847627040466 ()


  • Helicobacter pylori antigen IVD, antibody
No Description
BIOCARE MEDICAL LLC
PM110L
In Commercial Distribution

  • 00847627040213 ()


  • CD3 cell marker IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI092T40
In Commercial Distribution

  • 00847627039866 ()


  • Calretinin protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI352T40
In Commercial Distribution

  • 00847627039828 ()


  • MUM1 transcription factor IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI390T40
In Commercial Distribution

  • 00847627039804 ()


  • Tissue prostate specific antigen (PSA) IVD, antibody
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