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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Rubella IgM (Rub M) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995668
In Commercial Distribution

  • 00630414599830 ()
10995668

  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Prostate Specific Antigen (PSA) - Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995664
In Commercial Distribution

  • 00630414599823 ()
10995664

  • Total prostate specific antigen (tPSA) IVD, control
Prostate Specific Antigen (PSA) - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995663
In Commercial Distribution

  • 00630414599816 ()
  • 00630414007755 ()
10995663

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Prostate Specific Antigen (PSA) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995662
In Commercial Distribution

  • 00630414599809 ()
10995662

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Progesterone (PRGE) Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995661
In Commercial Distribution

  • 00630414599793 ()
10995661

  • Progesterone IVD, control
Progesterone (PRGE) Atellica IM - RGT 90T
Siemens Healthcare Diagnostics Inc.
10995660
In Commercial Distribution

  • 00630414599786 ()
10995660

  • Progesterone IVD, kit, chemiluminescent immunoassay
Progesterone (PRGE) Atellica IM - RGT 450T
Siemens Healthcare Diagnostics Inc.
10995659
In Commercial Distribution

  • 00630414599779 ()
10995659

  • Progesterone IVD, kit, chemiluminescent immunoassay
Prolactin (PRL) Atellica IM - Master Curve Material Kit 9x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995657
In Commercial Distribution

  • 00630414599755 ()
10995657

  • Prolactin IVD, control
Prolactin (PRL) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995656
In Commercial Distribution

  • 00630414599748 ()
10995656

  • Prolactin IVD, kit, chemiluminescent immunoassay
Prolactin (PRL) Atellica IM - RGT 250
Siemens Healthcare Diagnostics Inc.
10995655
In Commercial Distribution

  • 00630414599731 ()
  • 00630414007748 ()
10995655

  • Prolactin IVD, kit, chemiluminescent immunoassay
Procalcitonin (PCT) QC Kit Atellica IM - CLT 2 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995652
In Commercial Distribution

  • 00630414599700 ()
10995652

  • Procalcitonin (PCT) IVD, control
Procalcitonin (PCT) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995651
In Commercial Distribution

  • 00630414599694 ()
10995651

  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
Myoglobin (MYO) Atellica IM - Master Curve Material Kit 8 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995650
In Commercial Distribution

  • 00630414599687 ()
10995650

  • Myoglobin IVD, control
Myoglobin (MYO) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995649
In Commercial Distribution

  • 00630414599670 ()
10995649

  • Myoglobin IVD, kit, chemiluminescent immunoassay
Myoglobin (MYO) Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995648
In Commercial Distribution

  • 00630414599663 ()
  • 00630414007731 ()
10995648

  • Myoglobin IVD, kit, chemiluminescent immunoassay
Multi-Diluent 5 Atellica IM - CONS (2 PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995647
Not in Commercial Distribution

  • 00630414599656 ()
  • 00630414007724 ()
10995647

  • Buffered sample diluent IVD
Multi-Diluent 3 Atellica IM CONS (2 PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995645
In Commercial Distribution

  • 00630414599632 ()
  • 00630414007700 ()
10995645

  • Buffered sample diluent IVD
Multi-Diluent 2 Atellica IM - CONS (2 PK) 1 x 10mL
Siemens Healthcare Diagnostics Inc.
10995644
In Commercial Distribution

  • 00630414599625 ()
  • 00630414007687 ()
10995644

  • Buffered sample diluent IVD
Multi-Diluent 13 Atellica IM - CONS (2 PK) 2 x 10mL
Siemens Healthcare Diagnostics Inc.
10995643
In Commercial Distribution

  • 00630414599618 ()
  • 00630414007670 ()
10995643

  • Buffered sample diluent IVD
Multi-Diluent 11 Atellica IM - CONS (2 PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995642
In Commercial Distribution

  • 00630414599601 ()
  • 00630414007663 ()
10995642

  • Buffered sample diluent IVD
Multi-Diluent 11 Atellica IM - CONS (Bottle) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995641
In Commercial Distribution

  • 00630414599595 ()
10995641

  • Buffered sample diluent IVD
Free T3 (FT3) Atellica IM - RGT 300T
Siemens Healthcare Diagnostics Inc.
10995584
In Commercial Distribution

  • 00630414599083 ()
  • 00630414007564 ()
10995584

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Follicle Stimulating Hormone (FSH) Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995582
In Commercial Distribution

  • 00630414599069 ()
10995582

  • Follicle stimulating hormone (FSH) IVD, control
Follicle Stimulating Hormone (FSH) Atellica IM - RGT 950T
Siemens Healthcare Diagnostics Inc.
10995581
In Commercial Distribution

  • 00630414599052 ()
  • 00630414007557 ()
10995581

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Follicle Stimulating Hormone (FSH) Atellica IM - RGT 190T
Siemens Healthcare Diagnostics Inc.
10995580
In Commercial Distribution

  • 00630414599045 ()
10995580

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Ferritin (Fer) Atellica IM - RGT 450T
Siemens Healthcare Diagnostics Inc.
10995568
In Commercial Distribution

  • 00630414598925 ()
  • 00630414007519 ()
10995568

  • Ferritin IVD, kit, chemiluminescent immunoassay
Enhanced Estradiol (eE2) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995564
In Commercial Distribution

  • 00630414598888 ()
10995564

  • Estradiol (oestradiol) (E2) IVD, control
Enhanced Estradiol (eE2) Diluent Atellica IM - CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995563
In Commercial Distribution

  • 00630414598871 ()
  • 00630414007502 ()
10995563

  • Buffered sample diluent IVD
Estradiol (eE2) Atellica IM RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995562
In Commercial Distribution

  • 00630414598864 ()
10995562

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
Estradiol (eE2) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995561
In Commercial Distribution

  • 00630414598857 ()
10995561

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
Digoxin (Dig) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995559
In Commercial Distribution

  • 00630414598833 ()
10995559

  • Digoxin therapeutic drug monitoring IVD, control
Digoxin (Dig) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995558
In Commercial Distribution

  • 00630414598826 ()
10995558

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay
Digoxin (Dig) Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995557
In Commercial Distribution

  • 00630414598819 ()
  • 00630414007496 ()
10995557

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay
DHEAS - Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995556
In Commercial Distribution

  • 00630414598802 ()
10995556

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control
DHEAS - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995555
In Commercial Distribution

  • 00630414598796 ()
10995555

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Digitoxin (Dgtn) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995554
Not in Commercial Distribution

  • 00630414598789 ()
10995554

  • Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Digitoxin (Dgtn) Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995553
Not in Commercial Distribution

  • 00630414598772 ()
  • 00630414007489 ()
10995553

  • Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Cyclosporine (CsA) Pretreatment Atellica IM - CONS (2PK) 2 x 26mL
Siemens Healthcare Diagnostics Inc.
10995552
In Commercial Distribution

  • 00630414598765 ()
  • 00630414007465 ()
10995552

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
Cyclosporine (CsA) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995551
In Commercial Distribution

  • 00630414598758 ()
10995551

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Cyclosporine (CsA) Multi-Diluent Atellica IM - CONS 1 x 20mL
Siemens Healthcare Diagnostics Inc.
10995550
In Commercial Distribution

  • 00630414598741 ()
10995550

  • Buffered sample diluent IVD
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