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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Vitamin D total 25 (OH) (VitD) Diluent Atellica IM CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995721
In Commercial Distribution

  • 00630414600345 ()
  • 00630414007946 ()
10995721

  • Buffered sample diluent IVD
Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995720
In Commercial Distribution

  • 00630414600338 ()
10995720

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995719
In Commercial Distribution

  • 00630414600321 ()
10995719

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Vitamin B12 (VB12) DTT/REL Atellica IM - CONS
Siemens Healthcare Diagnostics Inc.
10995718
In Commercial Distribution

  • 00630414600314 ()
10995718

  • Vitamin B12 IVD, reagent
Vitamin B12 (VB12) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995717
In Commercial Distribution

  • 00630414600307 ()
10995717

  • Vitamin B12 IVD, control
Vitamin B12 (VB12) Diluent Atellica IM - CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995716
In Commercial Distribution

  • 00630414600291 ()
  • 00630414007908 ()
10995716

  • Buffered sample diluent IVD
Vitamin B12 (VB12) Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995715
In Commercial Distribution

  • 00630414600284 ()
  • 00630414007892 ()
10995715

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Vitamin B12 (VB12) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995714
In Commercial Distribution

  • 00630414600277 ()
10995714

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
T Uptake (Tup) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995712
In Commercial Distribution

  • 00630414600253 ()
10995712

  • Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay
T Uptake (Tup) Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995711
In Commercial Distribution

  • 00630414600246 ()
  • 00630414007885 ()
10995711

  • Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay
Testoterone II (TSTII) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995709
In Commercial Distribution

  • 00630414600239 ()
10995709

  • Total testosterone IVD, control
Testoterone II (TSTII) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995708
In Commercial Distribution

  • 00630414600222 ()
10995708

  • Total testosterone IVD, kit, chemiluminescent immunoassay
Testoterone II (TSTII) Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995707
In Commercial Distribution

  • 00630414600215 ()
10995707

  • Total testosterone IVD, kit, chemiluminescent immunoassay
TSH3-UL Atellica IM - Master Curve Material Kit 10 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995705
In Commercial Distribution

  • 00630414600185 ()
10995705

  • Thyroid stimulating hormone (TSH) IVD, control
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) - Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995694
In Commercial Distribution

  • 00630414600079 ()
10995694

  • Total human chorionic gonadotropin IVD, control
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
HCG Total (ThCG) Diluent - Atellica IM - CONS - (6PK) 6 x 25mL
Siemens Healthcare Diagnostics Inc.
10995692
In Commercial Distribution

  • 00630414600055 ()
  • 00630414007830 ()
10995692

  • Buffered sample diluent IVD
HCG Total (ThCG) Diluent - Atellica IM - CONS - (2PK) 2 x 25mL
Siemens Healthcare Diagnostics Inc.
10995691
In Commercial Distribution

  • 00630414600048 ()
  • 00630414007823 ()
10995691

  • Buffered sample diluent IVD
HCG Total (ThCG) Atellica IM - RGT - 90T
Siemens Healthcare Diagnostics Inc.
10995690
In Commercial Distribution

  • 00630414600031 ()
10995690

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
HCG Total (ThCG) Atellica IM - RGT - 450T
Siemens Healthcare Diagnostics Inc.
10995689
In Commercial Distribution

  • 00630414600024 ()
  • 00630414007816 ()
10995689

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
T4 Total (T4) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995687
In Commercial Distribution

  • 00630414600000 ()
10995687

  • Total thyroxine (TT4) IVD, control
T4 Total (T4) Diluent Bottle Atellica IM - CONS 1 x 10mL
Siemens Healthcare Diagnostics Inc.
10995686
In Commercial Distribution

  • 00630414599991 ()
10995686

  • Buffered sample diluent IVD
Total T4 (T4) Atellica IM - RGT 750T
Siemens Healthcare Diagnostics Inc.
10995685
In Commercial Distribution

  • 00630414599984 ()
  • 00630414007809 ()
10995685

  • Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
Total T4 (T4) Atellica IM - RGT 150T
Siemens Healthcare Diagnostics Inc.
10995684
In Commercial Distribution

  • 00630414599977 ()
10995684

  • Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
T3/T4/VB12 Ancillary Reagent Atellica IM - CAL (6PK) 6 x 25mL
Siemens Healthcare Diagnostics Inc.
10995683
In Commercial Distribution

  • 00630414599960 ()
  • 00630414007793 ()
10995683

  • Multiple thyroid marker IVD, reagent
T3/T4/VB12 Ancillary Reagent Atellica IM – CAL (2PK) 2 x 25mL
Siemens Healthcare Diagnostics Inc.
10995682
In Commercial Distribution

  • 00630414599953 ()
  • 00630414007779 ()
10995682

  • Multiple thyroid marker IVD, reagent
T3 Total (T3) Atellica IM - Master Curve Material Kit 8 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995681
In Commercial Distribution

  • 00630414599946 ()
10995681

  • Total triiodothyronine (TT3) IVD, control
T3 Total (T3) Diluent Bottle Atellica IM - CONS 1 x 10mL
Siemens Healthcare Diagnostics Inc.
10995680
In Commercial Distribution

  • 00630414599939 ()
10995680

  • Buffered sample diluent IVD
T3 Total (T3) Atellica IM - RGT 120T
Siemens Healthcare Diagnostics Inc.
10995679
In Commercial Distribution

  • 00630414599922 ()
10995679

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
T3 Total (T3) Atellica IM - RGT 600T
Siemens Healthcare Diagnostics Inc.
10995678
In Commercial Distribution

  • 00630414599915 ()
  • 00630414007762 ()
10995678

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
Syphillis (Syph) QC Kit Atellica IM - CLT 2 x 2 x 7.0mL
Siemens Healthcare Diagnostics Inc.
10995676
In Commercial Distribution

  • 00630414599892 ()
10995676

  • Treponema pallidum total antibody IVD, control
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