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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Progesterone (PRGE) - Atellica IM - RGT 450T
Siemens Healthcare Diagnostics Inc.
11206257
In Commercial Distribution

  • 00630414294216 ()
  • 00630414293714 ()
11206257

  • Progesterone IVD, kit, chemiluminescent immunoassay
Luteinizing Hormone (LH) - Atellica IM - RGT - 550T
Siemens Healthcare Diagnostics Inc.
11206256
In Commercial Distribution

  • 00630414294209 ()
  • 00630414293707 ()
11206256

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Insulin (IRI) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11206267
In Commercial Distribution

  • 00630414293691 ()
11206267

  • Insulin IVD, kit, chemiluminescent immunoassay
Free T4 (FT4) - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206255
In Commercial Distribution

  • 00630414294193 ()
  • 00630414293684 ()
11206255

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Free T3 (FT3) - Atellica IM - RGT 300T
Siemens Healthcare Diagnostics Inc.
11206254
In Commercial Distribution

  • 00630414294186 ()
  • 00630414293677 ()
11206254

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
CEA - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206246
In Commercial Distribution

  • 00630414294131 ()
  • 00630414293585 ()
11206246

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
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
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
CA 15-3 Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206238
In Commercial Distribution

  • 00630414294063 ()
  • 00630414293509 ()
11206238

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
BR Calibrator - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206237
In Commercial Distribution

  • 00630414294056 ()
  • 00630414293486 ()
11206237

  • Cancer antigen 27-29 (CA27-29) IVD, calibrator
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