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 Class Implantable

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Sex Hormone Binding Globulin (SHBG) - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206312
In Commercial Distribution

  • 00630414294285 ()
  • 00630414293868 ()
11206312

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
DHEAS - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206311
In Commercial Distribution

  • 00630414293844 ()
11206311

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Vitamin D total 25(OH) (VitD) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206265
In Commercial Distribution

  • 00630414293837 ()
11206265

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Vitamin B12 (VB12) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206264
In Commercial Distribution

  • 00630414294261 ()
  • 00630414293820 ()
11206264

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Testoterone II (TSTII) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206263
In Commercial Distribution

  • 00630414293813 ()
11206263

  • Total testosterone IVD, kit, chemiluminescent immunoassay
TSH3-UL - Atellica IM - RGT 550T
Siemens Healthcare Diagnostics Inc.
11206304
In Commercial Distribution

  • 00630414293806 ()
11206304

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TnI-Ultra - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206219
In Commercial Distribution

  • 00630414293790 ()
11206219

  • Troponin I IVD, kit, chemiluminescent immunoassay
High Sensitivity Troponin I (TnIH) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206269
In Commercial Distribution

  • 00630414293783 ()
11206269

  • Troponin I IVD, kit, chemiluminescent immunoassay
HCG Total (ThCG) - Atellica IM - RGT - 450T
Siemens Healthcare Diagnostics Inc.
11206261
In Commercial Distribution

  • 00630414294254 ()
  • 00630414293776 ()
11206261

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
T3 Total (T3) - Atellica IM - RGT 600T
Siemens Healthcare Diagnostics Inc.
11206260
In Commercial Distribution

  • 00630414294247 ()
  • 00630414293769 ()
11206260

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
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