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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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PDX1 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB31610 ()
BSB 3161

  • Biological stain control IVD
PD-1/CD279 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB31540 ()
BSB 3154

  • Multiple CD cell marker IVD, control
PAX-8 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB31470 ()
BSB 3147

  • Biological stain control IVD
OX-40/CD134 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB31260 ()
BSB 3126

  • Multiple CD cell marker IVD, control
NKX3.1 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB31190 ()
BSB 3119

  • Biological stain control IVD
NKX2.2 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB31120 ()
BSB 3112

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

  • B502BSB31050 ()
BSB 3105

  • Neutrophil elastase IVD, control
Detection system intended for the fast immunohistochemical detection of antibodies used for Mohs surgery on frozen or FFPE tissue sections.
BIO SB, INC.
Kit, 5 ml
In Commercial Distribution

  • B502BSB307S0 ()
0307S

  • Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
IgE Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB30730 ()
BSB 3073

  • Total immunoglobulin E (IgE total) IVD, control
Fibrinogen Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB30530 ()
BSB 3053

  • Fibrinogen assay (factor I) IVD, control
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