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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 CA 19-9 - 00630414598178

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

Atellica IM CA 19-9 - 00630414598161

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

Atellica IM CA 15-3 MCM - 00630414598154

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

Atellica IM CA 15-3® Calibrator - 00630414598147

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

Atellica IM CA 15-3 - 00630414598130

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

Atellica IM CA 15-3 - 00630414598123

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

Atellica IM CA 125II MCM - 00630414598116

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

Atellica IM CA 125II Calibrator - 00630414598109

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

Atellica IM CA 125II - 00630414598093

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

Atellica IM CA 125II - 00630414598086

CA 125II Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995481
In Commercial Distribution

  • 00630414598086 ()
10995481

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Atellica IM BR PRE - 00630414598079

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

Atellica IM BR MCM - 00630414598062

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

Atellica IM BR - 00630414598055

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

Atellica IM BR - 00630414598048

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

Atellica IM BNP QC - 00630414598024

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

Atellica IM BNP MCM - 00630414598017

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

Atellica IM BNP Calibrator - 00630414598000

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

Atellica IM BNP - 00630414597997

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

Atellica IM BNP - 00630414597980

BNP - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995471
In Commercial Distribution

  • 00630414597980 ()
10995471

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

Atellica IM aTPO QC - 00630414597973

TPO Ab QC Kit - Atellica IM - CLT 2 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995470
In Commercial Distribution

  • 00630414597973 ()
10995470

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control

Atellica IM aTPO MCM - 00630414597966

TPO Ab - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995469
In Commercial Distribution

  • 00630414597966 ()
10995469

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control

Atellica IM aTPO DIL - 00630414597959

TPOAb Ancillary Diluent - Atellica IM - CONS 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995468
In Commercial Distribution

  • 00630414597959 ()
  • 00630414007328 ()
10995468

  • Buffered sample diluent IVD

Atellica IM aTPO - 00630414597942

TPO Ab - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995467
In Commercial Distribution

  • 00630414597942 ()
  • 00630414007311 ()
10995467

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay

Atellica IM aTPO - 00630414597935

TPO Ab - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995466
In Commercial Distribution

  • 00630414597935 ()
10995466

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay

Atellica IM aTG QC - 00630414597928

TG Ab QC Kit - Atellica IM - CLT 2 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995465
In Commercial Distribution

  • 00630414597928 ()
10995465

  • Thyroglobulin antibody IVD, control

Atellica IM aTG MCM - 00630414597911

TG Ab - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995464
In Commercial Distribution

  • 00630414597911 ()
10995464

  • Thyroglobulin antibody IVD, control

Atellica IM aTG DIL - 00630414597904

TG Ab Ancillary Diluent - Atellica IM - CONS - 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995463
In Commercial Distribution

  • 00630414597904 ()
  • 00630414007304 ()
10995463

  • Buffered sample diluent IVD

Atellica IM aTG - 00630414597898

TG Ab - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995462
In Commercial Distribution

  • 00630414597898 ()
  • 00630414007298 ()
10995462

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

Atellica IM aTG - 00630414597881

TG Ab - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995461
In Commercial Distribution

  • 00630414597881 ()
10995461

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

Atellica™ IM aHCV QC - 00630414597874

HCV (aHCV) QC Kit - Atellica IM - CLT 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995457
In Commercial Distribution

  • 00630414597874 ()
10995457

  • Hepatitis C virus total antibody IVD, control
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