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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 Cor - 00630414293608

Cortisol - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206248
In Commercial Distribution

  • 00630414294155 ()
  • 00630414293608 ()
11206248

  • Total cortisol IVD, kit, chemiluminescent immunoassay

Atellica IM CKMB - 00630414293592

CKMB - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206247
In Commercial Distribution

  • 00630414294148 ()
  • 00630414293592 ()
11206247

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

Atellica IM CEA - 00630414293585

CEA - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206246
In Commercial Distribution

  • 00630414294131 ()
  • 00630414293585 ()
11206246

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

Atellica IM Calibrator E - 00630414293578

Calibrator E - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206245
In Commercial Distribution

  • 00630414294124 ()
  • 00630414293578 ()
11206245

  • Multiple steroid hormone IVD, calibrator

Atellica IM Calibrator D - 00630414293561

Calibrator D - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206244
In Commercial Distribution

  • 00630414294117 ()
  • 00630414293561 ()
11206244

  • Multiple tissue-associated protein/tumour marker IVD, calibrator

Atellica IM Calibrator C - 00630414293554

Calibrator C - Atellica IM - CAL (6PK) 6 x 2 x 5.0 mL
Siemens Healthcare Diagnostics Inc.
11206243
In Commercial Distribution

  • 00630414294100 ()
  • 00630414293554 ()
11206243

  • Multiple anaemia-related analyte IVD, calibrator

Atellica IM Calibrator B - 00630414293547

Calibrator B - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206242
In Commercial Distribution

  • 00630414294094 ()
  • 00630414293547 ()
11206242

  • Multiple human hormone IVD, calibrator

Atellica IM Calibrator A - 00630414293530

Calibrator A - Atellica IM - CAL (6PK) 2 x 6 x 5.0 mL
Siemens Healthcare Diagnostics Inc.
11206241
In Commercial Distribution

  • 00630414294087 ()
  • 00630414293530 ()
11206241

  • Multiple human hormone IVD, calibrator

Atellica IM Calibrator 30 - 00630414293523

Calibrator 30 - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206240
In Commercial Distribution

  • 00630414294070 ()
  • 00630414293523 ()
11206240

  • Multiple steroid hormone IVD, calibrator

Atellica IM CA 19-9 - 00630414293516

CA 19-9 Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206239
In Commercial Distribution

  • 00630414293516 ()
11206239

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
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