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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HBC Total Ab (HBcT) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207276
In Commercial Distribution

  • 00630414301303 ()
11207276

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
HAV Total Ab (aHAVT) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207271
In Commercial Distribution

  • 00630414301297 ()
11207271

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
CHIV - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207266
In Commercial Distribution

  • 00630414301280 ()
11207266

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207255
In Commercial Distribution

  • 00630414301273 ()
11207255

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207249
In Commercial Distribution

  • 00630414301266 ()
11207249

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
HAV IgM Ab (aHAVM) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11207243
In Commercial Distribution

  • 00630414301259 ()
11207243

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
TSH3-UL - Atellica IM - RGT 2750T
Siemens Healthcare Diagnostics Inc.
11206262
In Commercial Distribution

  • 00630414293875 ()
11206262

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
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 B12 (VB12) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206264
In Commercial Distribution

  • 00630414294261 ()
  • 00630414293820 ()
11206264

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
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