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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Hepatitis Be Antigen (HBeAg) - Atellica IM - RGT - 50T
Siemens Healthcare Diagnostics Inc.
11207281
In Commercial Distribution

  • 00630414301310 ()
11207281

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
Free T4 (FT4) - Atellica IM - RGT 1250T
Siemens Healthcare Diagnostics Inc.
11206313
In Commercial Distribution

  • 00630414294292 ()
  • 00630414293851 ()
11206313

  • Free thyroxine (FT4) 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
TSH3-UL - Atellica IM - RGT 550T
Siemens Healthcare Diagnostics Inc.
11206304
In Commercial Distribution

  • 00630414293806 ()
11206304

  • Thyroid stimulating hormone (TSH) 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
Sex Hormone Binding Globulin (SHBG) - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
11206215
In Commercial Distribution

  • 00630414293752 ()
11206215

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
Intact Parathyroid Hormone (PTH) - Atellica IM - RGT 950T
Siemens Healthcare Diagnostics Inc.
11206268
In Commercial Distribution

  • 00630414293745 ()
11206268

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Prostate Specific Antigen (PSA) - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
11206259
In Commercial Distribution

  • 00630414294230 ()
  • 00630414293738 ()
11206259

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Prolactin (PRL) - Atellica IM - RGT 250
Siemens Healthcare Diagnostics Inc.
11206258
In Commercial Distribution

  • 00630414294223 ()
  • 00630414293721 ()
11206258

  • Prolactin IVD, kit, chemiluminescent immunoassay
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