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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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BRAF V600E Control slides
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB28300 ()
BSB 2830

  • BRAF V600 gene mutation IVD, control
bcl-6 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB28230 ()
BSB 2823

  • Bcl-6 protein IVD, control
B7H3/CD276 RMab, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB28160 ()
BSB 2816

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

  • B502BSB28090 ()
BSB 2809

  • Amyloid A component IVD, control
ALK RMab Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB28020 ()
BSB 2802

  • Anaplastic lymphoma kinase IVD, control
Desmoglein-3- Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB27950 ()
BSB 2795

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

  • B502BSB27670 ()
BSB 2767

  • Thyroglobulin IVD, control
PLAP Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB27600 ()
BSB 2760

  • Human placental alkaline phosphatase (hPLAP) IVD, control
Parafibromin- Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB27530 ()
BSB 2753

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

  • B502BSB27460 ()
BSB 2746

  • Estrogen (oestrogen)/progesterone receptor IVD, control
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