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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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
Multi-Diluent 10 Atellica IM - CONS (2 PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995640
In Commercial Distribution

  • 00630414599588 ()
  • 00630414007656 ()
10995640

  • Buffered sample diluent IVD
Multi-Diluent 1 Atellica IM - CONS (Bottle) 1 x 50mL
Siemens Healthcare Diagnostics Inc.
10995639
In Commercial Distribution

  • 00630414599571 ()
10995639

  • Buffered sample diluent IVD
Multi-Diluent 1 Atellica IM - CONS (6PK) 6 x 25mL
Siemens Healthcare Diagnostics Inc.
10995638
In Commercial Distribution

  • 00630414599564 ()
  • 00630414007649 ()
10995638

  • Buffered sample diluent IVD
Multi-Diluent 1 Atellica IM - CONS (2PK) 2 x 25mL
Siemens Healthcare Diagnostics Inc.
10995637
In Commercial Distribution

  • 00630414599557 ()
  • 00630414007632 ()
10995637

  • Buffered sample diluent IVD
Luteinizing Hormone (LH) Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995636
In Commercial Distribution

  • 00630414599540 ()
10995636

  • Luteinizing hormone (LH) IVD, control
Luteinizing Hormone (LH) Atellica IM - RGT - 110T
Siemens Healthcare Diagnostics Inc.
10995635
In Commercial Distribution

  • 00630414599533 ()
10995635

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Luteinizing Hormone (LH) Atellica IM - RGT - 550T
Siemens Healthcare Diagnostics Inc.
10995634
In Commercial Distribution

  • 00630414599526 ()
  • 00630414007625 ()
10995634

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Intact parathyroid hormone (iPTH) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995626
In Commercial Distribution

  • 00630414599496 ()
10995626

  • Parathyroid hormone (PTH) IVD, control
Intact parathyroid hormone (iPTH) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995625
In Commercial Distribution

  • 00630414599489 ()
10995625

  • Parathyroid hormone (PTH) IVD, control
Intact Parathyroid Hormone (iPTH) Atellica IM - RGT 950T
Siemens Healthcare Diagnostics Inc.
10995622
In Commercial Distribution

  • 00630414599458 ()
10995622

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Intact Parathyroid Hormone (iPTH) Atellica IM - RGT 190T
Siemens Healthcare Diagnostics Inc.
10995621
In Commercial Distribution

  • 00630414599441 ()
10995621

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Total IgE (tIgE) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995617
In Commercial Distribution

  • 00630414599403 ()
10995617

  • Total immunoglobulin E (IgE total) IVD, control
IgE Multi-Diluent Atellica IM - CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995616
In Commercial Distribution

  • 00630414599397 ()
  • 00630414007618 ()
10995616

  • Buffered sample diluent IVD
IgE (tIgE) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995615
In Commercial Distribution

  • 00630414599380 ()
10995615

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
IgE (tIgE) Atellica IM – RGT 250T
Siemens Healthcare Diagnostics Inc.
10995614
In Commercial Distribution

  • 00630414599373 ()
  • 00630414007601 ()
10995614

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
HIV 1/O/2 (eHIV) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995611
In Commercial Distribution

  • 00630414599342 ()
10995611

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Homocysteine (HYC) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995609
In Commercial Distribution

  • 00630414599328 ()
10995609

  • Homocysteine IVD, control
Homocysteine (HYC) Multi-Diluent Atellica IM - CONS (2PK) 2 x 10mL
Siemens Healthcare Diagnostics Inc.
10995608
In Commercial Distribution

  • 00630414599311 ()
  • 00630414007595 ()
10995608

  • Buffered sample diluent IVD
Homocysteine (HYC) Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995607
In Commercial Distribution

  • 00630414599304 ()
10995607

  • Homocysteine IVD, kit, chemiluminescent immunoassay
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