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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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Fungus: Aspergillus, Candida, Histoplasma TMA, Artificial (4-core: 3 Positives and 1 Negative)- Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB0340CS0 ()
BSB-0340-CS

  • Biological stain control IVD
Treponema TMA, Artificial (2-core: Positive and Negative)- Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB0339CS0 ()
BSB-0338-CS

  • Biological stain control IVD
Treponema TMA, Artificial (2-core: Positive and Negative)- Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB0338CS0 ()
BSB-0338-CS

  • Biological stain control IVD
4-core MMR Cell Line Microarray cell line cores assembled in array fashion used as control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB0337CS0 ()
BSB-0337-CS

  • Biological stain control IVD
3-core IDH1 R132H Cell Line Microarray cell line cores assembled in array fashion used as control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB0336CS0 ()
BSB-0336-CS

  • Biological stain control IVD
3-core ROS1 Cell Line Microarray cell line cores assembled in array fashion used as control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB0335CS0 ()
BSB-0335-CS

  • Biological stain control IVD
3-core Androgen Receptor Cell Line Microarray cell line cores assembled in array fashion used as control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB0334CS0 ()
BSB-0334-CS

  • Biological stain control IVD
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

  • B502BSB0310S0 ()
BSB 0310S

  • Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
3-core Lung Cancer Cell Line Microarray cell line cores assembled in array fashion used as control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB03060 ()
BSB 0306

  • Biological stain control IVD
5-core BRAF V600E Cell Line Microarray cell line cores assembled in array fashion used as control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB03050 ()
BSB 0305

  • Biological stain control IVD
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