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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ATELLICA CH LID KEYING FEATURE KIT
Siemens Healthcare Diagnostics Inc.
11597266
In Commercial Distribution

  • 00630414304328 ()
11597266

  • Instrument/analyser test tube rack cover IVD
HA1C_E HIGH VOLUME LABEL KIT ATELLICA CH (50 LABELS)
Siemens Healthcare Diagnostics Inc.
11597090
In Commercial Distribution

  • 00630414304311 ()
11597090

  • Printer label IVD
HA1C_E HIGH VOLUME BOTTLE KIT ATELLICA CH (5 BOTTLES)
Siemens Healthcare Diagnostics Inc.
11597087
In Commercial Distribution

  • 00630414304304 ()
11597087

  • Assay container IVD, reusable
Atellica IM aHCV 200T Kit
Siemens Healthcare Diagnostics Inc.
11207260
In Commercial Distribution

  • 00630414301341 ()
11207260

  • Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
Vitamin D total 25(OH) (VitD) QC Kit Atellica IM - CLT 2 x 3 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11207292
In Commercial Distribution

  • 00630414301334 ()
11207292

  • Multiple form 25-hydroxy Vitamin D IVD, control
HBsAgII (HBsII) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207286
In Commercial Distribution

  • 00630414301327 ()
11207286

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
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
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
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