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 Class Implantable

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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
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 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 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
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
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
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
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
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