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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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Galectin-3 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB55460 ()
BSB 5546

  • Galectin-3 IVD, control
FSH, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB55390 ()
BSB 5539

  • Follicle stimulating hormone (FSH) IVD, control
Follicular Dendritic Cell Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB55320 ()
BSB 5532

  • Biological stain control IVD
Fli-1 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB55250 ()
BSB 5525

  • Biological stain control IVD
Fascin, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB55180 ()
BSB 5518

  • Fascin IVD, control
Factor XIIIa, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB55110 ()
BSB 5511

  • Coagulation factor XIIIa pro-enzyme subunit IVD, control
Factor VIII-Related Antigen, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB55040 ()
BSB 5504

  • Coagulation factor VIII-associated antigen IVD, control
Estrogen Receptor, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB54970 ()
BSB 5497

  • Estrogen (oestrogen)/progesterone receptor IVD, control
Epstein Barr Virus LMP-1, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB54900 ()
BSB 5490

  • Epstein-Barr virus (EBV) antigen IVD, control
EMA, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB54830 ()
BSB 5483

  • Epithelial membrane antigen (EMA) IVD, control
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