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 Class Implantable

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TSH3-UL Atellica IM - RGT 550T
Siemens Healthcare Diagnostics Inc.
10995704
In Commercial Distribution

  • 00630414600178 ()
10995704

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-UL Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995703
In Commercial Distribution

  • 00630414600161 ()
10995703

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Toxoplasma M IgM (ToxM) QC Kit Atellica IM - CLT 2 x 2 x 1.5mL
Siemens Healthcare Diagnostics Inc.
10995702
In Commercial Distribution

  • 00630414600154 ()
10995702

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control
Toxoplasma M - IgM (ToxM) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995701
In Commercial Distribution

  • 00630414600147 ()
10995701

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Toxoplasma G - IgG (ToxG) QC Kit Atellica IM - CLT 2 x 2 x 2.7mL
Siemens Healthcare Diagnostics Inc.
10995700
In Commercial Distribution

  • 00630414600130 ()
10995700

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
Toxoplasma G - IgG (ToxG) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995699
In Commercial Distribution

  • 00630414600123 ()
10995699

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
TnI-Ultra Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995698
In Commercial Distribution

  • 00630414600116 ()
10995698

  • Troponin I IVD, control
TnI-Ultra Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995697
In Commercial Distribution

  • 00630414600109 ()
10995697

  • Troponin I IVD, kit, chemiluminescent immunoassay
TnI-Ultra Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995696
In Commercial Distribution

  • 00630414600093 ()
10995696

  • Troponin I IVD, kit, chemiluminescent immunoassay
HCG Total (ThCG) Diluent Bottle - Atellica IM - CONS 1 x 50mL
Siemens Healthcare Diagnostics Inc.
10995693
In Commercial Distribution

  • 00630414600062 ()
10995693

  • Buffered sample diluent IVD
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