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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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 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
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