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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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Hepatitis B Virus Surface Antigen Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56230 ()
BSB 5623

  • Hepatitis B virus surface antigen IVD, control
Hepatitis B Virus Core Antigen Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56160 ()
BSB 5616

  • Hepatitis B virus core antigen IVD, control
Helicobacter pylori Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56090 ()
BSB 5609

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
hCG Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56020 ()
BSB5602

  • Total human chorionic gonadotropin IVD, control
Granzyme B, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB55950 ()
BSB 5595

  • Granzyme B IVD, control
Glycophorin A Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB55880 ()
BSB 5588

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

  • B502BSB55740 ()
BSB 5574

  • Growth hormone antibody IVD, control
GFAP Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB55670 ()
BSB 5567

  • Glial fibrillary acidic protein (GFAP) IVD, control
GCDFP-15, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB55600 ()
BSB 5560

  • Gross cystic disease fluid protein-15 IVD, control
Gastrin, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB55530 ()
BSB 5553

  • Gastrin IVD, control
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