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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
CD6 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB27110 ()
BSB 2711

  • Multiple CD cell marker IVD, control
bcl-10, Control
BIO SB, INC.
Control Slides, 5
Not in Commercial Distribution

  • B502BSB27040 ()
BSB 2704

  • Bcl-10 protein IVD, control
Herpes Simplex Virus I, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB26900 ()
BSB 2690

  • Herpes simplex virus 1 (HSV1) antigen IVD, control
Helicobacter Pylori Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB26830 ()
BSB 2683

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
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