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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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23-core Human Cancer TMA- Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB02310 ()
BSB 0231

  • Biological stain control IVD
11-core Human Cancer TMA- Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB02300 ()
BSB 0230

  • Biological stain control IVD
Mouse/Rabbit PolyDetector AEC HRP Red is a one-step polymeric detection system that allows for the demonstration of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.
BIO SB, INC.
5 ml each
In Commercial Distribution

  • B502BSB0202S0 ()
BSB 0202S

  • Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
Mouse/Rabbit PolyDetector DAB HRP Brown System is a one-step polymeric detection system that allows for the demonstration of antigens in formalin-fixed paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.
BIO SB, INC.
5 ml each
In Commercial Distribution

  • B502BSB0201S0 ()
BSB 0201S

  • Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
High sensitivity 2-step detection system designed for detection of specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.
BIO SB, INC.
5 ml each
In Commercial Distribution

  • B502BSB0002S0 ()
BSB 0002S

  • Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
High sensitivity 2-step detection system designed for detection of specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.
BIO SB, INC.
5 ml each
In Commercial Distribution

  • B502BSB0001S0 ()
BSB 0001S

  • Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
Cytokeratin 8 &18 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB54200 ()
BSB 5420

  • Cytokeratin IVD, control
Cytokeratin HMW 34BE12 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB53990 ()
BSB 5399

  • Cytokeratin IVD, control
Cytokeratin 19 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB53850 ()
BSB 5385

  • Cytokeratin IVD, control
CEA, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB53430 ()
BSB 5343

  • Carcinoembryonic antigen (CEA) IVD, control
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