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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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CD61 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB35170 ()
BSB 3517

  • Multiple CD cell marker IVD, control
CD42b Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB35100 ()
BSB 3510

  • Multiple CD cell marker IVD, control
Herpes Simplex Virus II, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB34680 ()
BSB 3468

  • Herpes simplex virus 2 (HSV2) antigen IVD, control
Mesothelial Cell, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB34610 ()
BSB 3461

  • Mesothelial cell IVD, control
Napsin A control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB33980 ()
BSB 3398

  • Biological stain control IVD
Langerin / CD207 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB33760 ()
BSB 3376

  • Biological stain control IVD
LAG-3 / CD223 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB33690 ()
BSB 3369

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

  • B502BSB33620 ()
BSB 3362

  • Inhibin A IVD, control
HE4 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB33550 ()
BSB 3355

  • Human epididymis protein 4 (HE4) IVD, control
GATA3 control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB33340 ()
BSB 3334

  • Biological stain control IVD
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