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

  • B502BSB30180 ()
BSB 3018

  • Albumin IVD, control
IgE / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3011CS0 ()
BSB 3011-CS

  • Total immunoglobulin E (IgE total) IVD, control
Lambda / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3010CS0 ()
BSB 3010-CS

  • Kappa/lambda light chain immunoglobulin IVD, control
Kappa / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3009CS0 ()
BSB 3009-CS

  • Kappa/lambda light chain immunoglobulin IVD, control
IgM / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3008CS0 ()
BSB 3008-CS

  • Total immunoglobulin M (IgM total) IVD, control
IgG / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3007CS0 ()
BSB 3007-CS

  • Total immunoglobulin G (IgG total) IVD, control
IgD / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3006CS0 ()
BSB 3006- CS

  • Total immunoglobulin D (IgD total) IVD, control
IgA / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3005CS0 ()
BSB 3005-CS

  • Immunoglobulin A antibody (anti-IgA) IVD, control
Fibrinogen / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3004CS0 ()
BSB 3004-CS

  • Fibrinogen assay (factor I) IVD, control
C4c / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3003CS0 ()
BSB 3003-CS

  • Complement components C4/C4c IVD, control
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