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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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Lambda -control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB36890 ()
BSB 3689

  • Kappa/lambda light chain immunoglobulin IVD, control
Kappa Control
BIO SB, INC.
Control Slides,5
In Commercial Distribution

  • B502BSB36880 ()
BSB 3688

  • Kappa/lambda light chain immunoglobulin IVD, control
IgM Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB36870 ()
BSB 3687

  • Total immunoglobulin M (IgM total) IVD, control
TCR Delta Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB36500 ()
BSB 3650

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

  • B502BSB36430 ()
BSB 3643

  • Biological stain control IVD
INSM1 control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB36360 ()
BSB 3636

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

  • B502BSB36290 ()
BSB 3629

  • Biological stain control IVD
PHOX2B- control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB36150 ()
BSB 3615

  • Biological stain control IVD
p63 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB36080 ()
BSB 3608

  • p63 tumour protein IVD, control
INSM1 control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB35590 ()
BSB 3559

  • Biological stain control IVD
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