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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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Reagent Red Blood Cells (Pooled Cells) Ortho® Coombs Control
ORTHO-CLINICAL DIAGNOSTICS, INC.
719810
In Commercial Distribution

  • 10758750004072 ()
719810

  • Immunoglobulin-sensitized reagent red blood cell IVD, control
SATB2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB32020 ()
BSB 3202

  • Zika virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
SATB2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB32010 ()
BSB 3201

  • Zika virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
SATB2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB31990 ()
BSB 3199

  • Zika virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
Tinto SATB2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB31980 ()
BSB 3198

  • Zika virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
SATB2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB31970 ()
BSB 3197

  • Zika virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
No Description
Shenzhen Osto Technology Co.,Ltd.
AST-300J
In Commercial Distribution

  • 06950940802155 ()
  • 06950940802148 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
Shenzhen Osto Technology Co.,Ltd.
AST-300L
In Commercial Distribution

  • 06950940802131 ()
  • 06950940802124 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
Shenzhen Osto Technology Co.,Ltd.
AST-300L
In Commercial Distribution

  • 06950940801875 ()
  • 06950940801868 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
Shenzhen Osto Technology Co.,Ltd.
AST-905D
In Commercial Distribution

  • 06950940801745 ()
  • 06950940801738 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control
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