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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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Atellica IM DHEAS MCM - 00630414598802

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

Atellica IM CsA PRE Pretreatment - 00630414598765

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

Atellica IM CsA MCM - 00630414598758

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

Atellica IM CsA Calibrator - 00630414598734

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

Atellica IM cPSA QC - 00630414598710

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

Atellica IM cPSA PRE - 00630414598703

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

Atellica IM cPSA MCM - 00630414598697

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

Atellica Cort Urine Recon Buffer - 00630414598673

Cortisol Urine Reconstitution Buffer Atellica IM - CONS 1 x 60mL
Siemens Healthcare Diagnostics Inc.
10995540
In Commercial Distribution

  • 00630414598673 ()
10995540

  • Total cortisol IVD, reagent

Atellica IM Cor MCM - 00630414598666

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

Atellica IM CKMB MCM - 00630414598611

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

Atellica IM CKMB Calibrator - 00630414598598

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

Atellica IM CHIV QC - 00630414598550

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

Atellica IM CEA MCM - 00630414598536

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

Atellica IM Calibrator Z - 00630414598482

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

Atellica IM Calibrator Y - 00630414598475

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

Atellica IM Calibrator U - 00630414598468

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

Atellica IM Calibrator Q - 00630414598451

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

Atellica IM Calibrator Q - 00630414598444

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

Atellica IM Calibrator O - 00630414598437

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

Atellica IM BR Calibrator - 00630414598420

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

Atellica IM Calibrator E - 00630414598406

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

Atellica IM Calibrator E - 00630414598390

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

Atellica IM Calibrator D - 00630414598376

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

Atellica IM Calibrator D - 00630414598369

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

Atellica IM Calibrator C - 00630414598345

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

Atellica IM Calibrator C - 00630414598338

Calibrator C - Atellica IM - CAL (2PK) 2 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995506
In Commercial Distribution

  • 00630414598338 ()
  • 00630414190785 ()
10995506

  • Multiple anaemia-related analyte IVD, calibrator

Atellica IM Calibrator B - 00630414598314

Calibrator B - Atellica IM CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995504
In Commercial Distribution

  • 00630414598314 ()
  • 00630414190778 ()
10995504

  • Multiple human hormone IVD, calibrator

Atellica IM Calibrator B - 00630414598307

Calibrator B - Atellica IM CAL (2PK) 2 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995503
In Commercial Distribution

  • 00630414598307 ()
  • 00630414190761 ()
10995503

  • Multiple human hormone IVD, calibrator

Atellica IM Calibrator A - 00630414598284

Calibrator A - Atellica IM CAL (6PK) 2 x 6 x 5.0 mL
Siemens Healthcare Diagnostics Inc.
10995501
In Commercial Distribution

  • 00630414598284 ()
  • 00630414190754 ()
10995501

  • Multiple human hormone IVD, calibrator

Atellica IM Calibrator A - 00630414598277

Calibrator A - Atellica IM CAL (2PK) 2 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995500
In Commercial Distribution

  • 00630414598277 ()
  • 00630414190747 ()
10995500

  • Multiple human hormone IVD, calibrator
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