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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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
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
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
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
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
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
Homocysteine Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995498
In Commercial Distribution

  • 00630414598253 ()
  • 00630414190730 ()
10995498

  • Homocysteine IVD, calibrator
Calibrator 80 Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995497
In Commercial Distribution

  • 00630414598246 ()
  • 00630414190716 ()
10995497

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator
Calibrator 30 Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995496
In Commercial Distribution

  • 00630414598239 ()
  • 00630414190709 ()
10995496

  • Multiple steroid hormone IVD, calibrator
Calibrator 30 Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995495
In Commercial Distribution

  • 00630414598222 ()
  • 00630414190686 ()
10995495

  • Multiple steroid hormone IVD, calibrator
Calibrator 1 Atellica IM - CAL (2PK) 2 x 2 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
10995493
In Commercial Distribution

  • 00630414598208 ()
  • 00630414190679 ()
10995493

  • Thyroglobulin antibody IVD, calibrator
CA 19-9 Atellica IM - Master Curve Material Kit 8 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995492
In Commercial Distribution

  • 00630414598192 ()
10995492

  • Cancer antigen 19-9 (CA19-9) IVD, control
CA 19-9 Diluent - Atellica IM - CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995491
In Commercial Distribution

  • 00630414598185 ()
  • 00630414007403 ()
10995491

  • Buffered sample diluent IVD
CA 19-9 - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995490
In Commercial Distribution

  • 00630414598178 ()
10995490

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
CA 19-9 Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995489
In Commercial Distribution

  • 00630414598161 ()
10995489

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
CA 15-3 Atellica IM Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995488
In Commercial Distribution

  • 00630414598154 ()
10995488

  • Cancer antigen 15-3 (CA15-3) IVD, control
CA 15-3® - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995487
In Commercial Distribution

  • 00630414598147 ()
  • 00630414190655 ()
10995487

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
CA 15-3 Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995486
In Commercial Distribution

  • 00630414598130 ()
  • 00630414007397 ()
10995486

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
CA 15-3 Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995485
In Commercial Distribution

  • 00630414598123 ()
10995485

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
CA 125II - Atellica IM - Master Curve Material Kit 8 x 1 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
10995484
In Commercial Distribution

  • 00630414598116 ()
10995484

  • Cancer antigen 125 (CA125) IVD, control
CA 125II Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995483
In Commercial Distribution

  • 00630414598109 ()
  • 00630414190648 ()
10995483

  • Cancer antigen 125 (CA125) IVD, calibrator
CA 125II Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995482
In Commercial Distribution

  • 00630414598093 ()
  • 00630414007380 ()
10995482

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
CA 125II Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995481
In Commercial Distribution

  • 00630414598086 ()
10995481

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
BR Pretreatment Atellica IM - CONS (2PK) 2 x 10mL
Siemens Healthcare Diagnostics Inc.
10995480
In Commercial Distribution

  • 00630414598079 ()
  • 00630414007366 ()
10995480

  • Cancer antigen 27-29 (CA27-29) IVD, reagent
BR CA27-29 Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995479
In Commercial Distribution

  • 00630414598062 ()
10995479

  • Cancer antigen 27-29 (CA27-29) IVD, control
BR CA27-29 Atellica IM - RGT - 50T
Siemens Healthcare Diagnostics Inc.
10995478
In Commercial Distribution

  • 00630414598055 ()
10995478

  • Cancer antigen 27-29 (CA27-29) IVD, kit, chemiluminescent immunoassay
BR CA27-29 Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995477
In Commercial Distribution

  • 00630414598048 ()
  • 00630414007359 ()
10995477

  • Cancer antigen 27-29 (CA27-29) IVD, kit, chemiluminescent immunoassay
BNP QC Kit Atellica IM - CLT 3 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995475
In Commercial Distribution

  • 00630414598024 ()
10995475

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
BNP Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995474
In Commercial Distribution

  • 00630414598017 ()
10995474

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
BNP - Atellica IM - CAL - (2 PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995473
In Commercial Distribution

  • 00630414598000 ()
  • 00630414190617 ()
10995473

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator
BNP - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995472
In Commercial Distribution

  • 00630414597997 ()
  • 00630414007342 ()
10995472

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
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