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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Dimenison Vista Lipase Flex reagent cartridge
Siemens Healthcare Diagnostics Inc.
11538128
In Commercial Distribution

  • 00630414306254 ()
  • 00630414292762 ()
K3056A

  • Lipase IVD, kit, spectrophotometry
Dimension Lipase (LIP) Flex reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
11538126
In Commercial Distribution

  • 00630414306247 ()
  • 00630414292748 ()
DF56A

  • Lipase IVD, kit, spectrophotometry
Lithium_2 (LITH_2) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11532401
In Commercial Distribution

  • 00630414287935 ()
11532401

  • Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy
Lactate_2 (Lac_2) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11532568
Not in Commercial Distribution

  • 00630414287270 ()
11532568

  • Lactate IVD, kit, spectrophotometry
Urine Oxycodone Screen Flex reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
11533385
In Commercial Distribution

  • 00630414295060 ()
  • 00630414287256 ()
DF98

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)
Anti-Mullerian Hormone (AMH) - Centaur - Quality Control Kit - 3 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11205264
In Commercial Distribution

  • 00630414286914 ()
11205264

  • Anti-Mullerian hormone (AMH) IVD, control
Zika Ab tellica IM Assay Kit 100T
Siemens Healthcare Diagnostics Inc.
11204647
In Commercial Distribution

  • 00630414286853 ()
11204647

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Zika IgM Atellica IM Assay Kit 50T
Siemens Healthcare Diagnostics Inc.
11204645
In Commercial Distribution

  • 00630414286839 ()
11204645

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Androstenedione (Andro) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
11200558
In Commercial Distribution

  • 00630414285566 ()
11200558

  • Androstenedione IVD, kit, chemiluminescent immunoassay
ISE Standard Urine - ADVIA Chem. - CAL - 2x100mL
Siemens Healthcare Diagnostics Inc.
10311904
In Commercial Distribution

  • 00630414210247 ()
B03-4176-01

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
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