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

  • B502BSB24180 ()
BSB 2418

  • Human placental lactogen (HPL) IVD, control
Granzyme B, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB24110 ()
BSB 2411

  • Granzyme B IVD, control
Anti-Claudin-, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB24040 ()
BSB 2404

  • Claudin protein IVD, antibody
Anti-Cadherin-6, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB23970 ()
BSB 2397

  • E-cadherin epithelial marker IVD, control
Alpha-Fetoprotein, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB23900 ()
BSB 2390

  • Alpha-fetoprotein (AFP) IVD, control
Tryptase, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB23830 ()
BSB 2383

  • Tryptase IVD, control
pan TRK- control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB2376CS0 ()
BSB-2376-CS

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

  • B502BSB2375CS0 ()
BSB-2375-CS

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

  • B502BSB2374CS0 ()
BSB-2374-CS

  • Melanoma specific protein IVD, control
PMS2-control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB2373CS0 ()
BSB-2373-CS

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, control
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