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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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
Cyclosporine (CsA) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995549
In Commercial Distribution

  • 00630414598734 ()
  • 00842768027383 ()
10995549

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Cyclosporine (CsA) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995548
In Commercial Distribution

  • 00630414598727 ()
10995548

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Complexed Prostate Specific Antigen (cPSA) QC Kit - Atellica IM - CLT 3 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995547
In Commercial Distribution

  • 00630414598710 ()
10995547

  • Complexed prostate specific antigen (cPSA) IVD, control
Complexed Prostate Specific Antigen (cPSA) Pretreatment - Atellica IM - CONS (1PK) 1 x 5mL
Siemens Healthcare Diagnostics Inc.
10995546
In Commercial Distribution

  • 00630414598703 ()
10995546

  • Complexed prostate specific antigen (cPSA) IVD, reagent
Complexed Prostate Specific Antigen (cPSA) - Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995545
In Commercial Distribution

  • 00630414598697 ()
10995545

  • Complexed prostate specific antigen (cPSA) IVD, control
Complexed Prostate Specific Antigen (cPSA) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995544
In Commercial Distribution

  • 00630414598680 ()
10995544

  • Complexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassay
Cortisol Urine Reconstitution Buffer Atellica IM - CONS 1 x 60mL
Siemens Healthcare Diagnostics Inc.
10995540
In Commercial Distribution

  • 00630414598673 ()
10995540

  • Total cortisol IVD, reagent
Cortisol (Cor) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995539
In Commercial Distribution

  • 00630414598666 ()
10995539

  • Total cortisol IVD, control
Cortisol - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995538
In Commercial Distribution

  • 00630414598659 ()
10995538

  • Total cortisol IVD, kit, chemiluminescent immunoassay
Cortisol - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995537
In Commercial Distribution

  • 00630414598642 ()
  • 00630414007458 ()
10995537

  • Total cortisol IVD, kit, chemiluminescent immunoassay
CKMB - Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995534
In Commercial Distribution

  • 00630414598611 ()
10995534

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, control
CKMB Diluent Atellica IM - CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995533
In Commercial Distribution

  • 00630414598604 ()
  • 00630414007441 ()
10995533

  • Buffered sample diluent IVD
CKMB Calibrator Atellica IM - CAL (2PK) 2 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995532
In Commercial Distribution

  • 00630414598598 ()
  • 00630414190938 ()
10995532

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator
CKMB Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995531
In Commercial Distribution

  • 00630414598581 ()
  • 00630414007434 ()
10995531

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
CKMB - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995530
In Commercial Distribution

  • 00630414598574 ()
10995530

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
CHIV QC Kit Atellica IM - CLT 5 x 1 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995528
In Commercial Distribution

  • 00630414598550 ()
10995528

  • HIV1/HIV2 antigen/antibody IVD, control
CEA - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995526
In Commercial Distribution

  • 00630414598536 ()
10995526

  • Carcinoembryonic antigen (CEA) IVD, control
CEA Diluent Atellica IM - CONS - (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995525
In Commercial Distribution

  • 00630414598529 ()
  • 00630414007427 ()
10995525

  • Buffered sample diluent IVD
CEA Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995524
In Commercial Distribution

  • 00630414598512 ()
  • 00630414007410 ()
10995524

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
CEA - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995523
In Commercial Distribution

  • 00630414598505 ()
10995523

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Calibrator Z - Atellica IM - CAL (2PK) 2 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995521
Not in Commercial Distribution

  • 00630414598482 ()
  • 00630414190921 ()
10995521

  • Digitoxin therapeutic drug monitoring IVD, calibrator
Calibrator Y - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995520
In Commercial Distribution

  • 00630414598475 ()
  • 00630414190914 ()
10995520

  • Complexed prostate specific antigen (cPSA) IVD, calibrator
Calibrator U - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995519
In Commercial Distribution

  • 00630414598468 ()
  • 00630414190907 ()
10995519

  • Myoglobin IVD, calibrator
Calibrator Q - Atellica IM - CAL (6PK) 6 x 2 x 2 mL
Siemens Healthcare Diagnostics Inc.
10995518
In Commercial Distribution

  • 00630414598451 ()
  • 00630414190891 ()
10995518

  • Total prostate specific antigen (tPSA) IVD, calibrator
Calibrator Q Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995517
In Commercial Distribution

  • 00630414598444 ()
  • 00630414190884 ()
10995517

  • Total prostate specific antigen (tPSA) IVD, calibrator
Calibrator O Atellica IM - CAL (2PK) 2 x 2 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
10995516
In Commercial Distribution

  • 00630414598437 ()
  • 00630414190877 ()
10995516

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, calibrator
BR Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995515
In Commercial Distribution

  • 00630414598420 ()
  • 00630414190846 ()
10995515

  • Cancer antigen 27-29 (CA27-29) IVD, calibrator
Calibrator E - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995513
In Commercial Distribution

  • 00630414598406 ()
  • 00630414190839 ()
10995513

  • Multiple steroid hormone IVD, calibrator
Calibrator E Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995512
In Commercial Distribution

  • 00630414598390 ()
  • 00630414190822 ()
10995512

  • Multiple steroid hormone IVD, calibrator
Calibrator D - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995510
In Commercial Distribution

  • 00630414598376 ()
  • 00630414190815 ()
10995510

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Calibrator D - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995509
In Commercial Distribution

  • 00630414598369 ()
  • 00630414190808 ()
10995509

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Calibrator C - Atellica IM - CAL (6PK) 6 x 2 x 5.0 mL
Siemens Healthcare Diagnostics Inc.
10995507
In Commercial Distribution

  • 00630414598345 ()
  • 00630414190792 ()
10995507

  • Multiple anaemia-related analyte IVD, calibrator
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