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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 Size Device Size Type Device Class Implantable

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ADVIA 120/2120/2120i Vent Line Wash Kit - 00842768027307

ADVIA 120/2120/2120i Vent Line Wash Kit
Siemens Healthcare Diagnostics Inc.
11306492
In Commercial Distribution

  • 00630414287102 ()
  • 00842768027307 ()
11306492

  • Wash/cleaning solution IVD, automated/semi-automated system

INNOVANCE® Antithrombin - 00842768027024

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10487304
In Commercial Distribution

  • 00842768027024 ()
OPFH07

  • Antithrombin III (ATIII) IVD, kit, chromogenic

INNOVANCE® Antithrombin - 00842768027017

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10487303
In Commercial Distribution

  • 00842768027017 ()
OPFH09

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Dimension Vista® ENZ 5 CAL - 00842768026911

Enzyme 5 Calibrator, 3x1.5mL
Siemens Healthcare Diagnostics Inc.
10464346
In Commercial Distribution

  • 00842768026911 ()
KC350

  • Multiple clinical chemistry enzyme IVD, calibrator

Siemens - 00842768026904

DM/VS Lipase Calibrator
Siemens Healthcare Diagnostics Inc.
10735073
Not in Commercial Distribution

  • 00842768026904 ()
DC56A

  • Lipase IVD, calibrator

Standard Human Plasma - 00842768026812

Standard Human Plasma for the calibration of coagulation and fibrinolysis tests
Siemens Healthcare Diagnostics Products GmbH
10487098
In Commercial Distribution

  • 00842768026812 ()
  • 00842768018893 ()
ORKL19

  • Multiple coagulation factor IVD, calibrator

Dimension Vista® ENZ 6 CAL - 00842768026614

Enzyme 6 Calibrator, 3x2.0mL
Siemens Healthcare Diagnostics Inc.
10464509
In Commercial Distribution

  • 00842768026614 ()
KC360

  • Multiple clinical chemistry enzyme IVD, calibrator

ADVIA Centaur® Zika Ab Assay 100T - 00842768026553

ADVIA Centaur® Zika Ab Assay
Siemens Healthcare Diagnostics Inc.
11200700
Not in Commercial Distribution

  • 00842768026553 ()
11200700

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Dimension Vista® LOCI 8 CAL - 00842768026492

LOCI 8 Calibrator, 2x5x2.5mL
Siemens Healthcare Diagnostics Inc.
10488192
In Commercial Distribution

  • 00842768026492 ()
KC646

  • Multiple human hormone IVD, calibrator

Dimension Vista® Total Testosterone Flex® Reagent Cartridge - 00842768026485

LOCI Total Testosterone Flex® reagent cartridge, 320 tests
Siemens Healthcare Diagnostics Inc.
10488399
In Commercial Distribution

  • 00842768026485 ()
  • 00630414016788 ()
K6465

  • Total testosterone IVD, kit, chemiluminescent immunoassay
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