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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Emit II Plus Specialty Multi Drug Calibrator/Control Level 2
Siemens Healthcare Diagnostics Inc.
10720813
In Commercial Distribution

  • 00630414027968 ()
9T549UL

  • Multiple drugs of abuse IVD, calibrator
Emit II Plus Specialty Multi Drug Calibrator/Control Level 3
Siemens Healthcare Diagnostics Inc.
10720814
In Commercial Distribution

  • 00630414027951 ()
9T569UL

  • Multiple drugs of abuse IVD, calibrator
Emit II Plus Specialty Multi Drug Calibrator/Control Level 4
Siemens Healthcare Diagnostics Inc.
10720815
In Commercial Distribution

  • 00630414027944 ()
9T589UL

  • Multiple drugs of abuse IVD, calibrator
Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720816
In Commercial Distribution

  • 00630414027937 ()
9T029UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)
Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720817
In Commercial Distribution

  • 00630414027920 ()
9T129UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)
A urine collection tube holder and plunger; to be used with DCA® Systems Microalbumin/Creatinine Reagent Cartridge.
Siemens Healthcare Diagnostics Inc.
10888739
In Commercial Distribution

  • 00630414027364 ()
  • 00630414211022 ()
10888739

  • Capillary blood collection tube IVD, no additive
The Xprecia Stride™ Coagulation System is intended for use by professional healthcare providers to provide an INR (InternationalNormalized Ratio) based on a Prothrobin time (PT) response for the monitoring of oral anticoagulation therapy with Warfarin.
Siemens Healthcare Diagnostics Inc.
11065584
In Commercial Distribution

  • 00630414025148 ()
11065584

  • Coagulation analyser IVD, point-of-care, battery-powered
Alpha-Fetoprotein (AFP) Assay Kit (1-pack) 100T
Siemens Healthcare Diagnostics Inc.
10998577
Not in Commercial Distribution

  • 00630414022963 ()
10998577

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITHOUT AUTOSAMPLER
Siemens Healthcare Diagnostics Inc.
11219531
In Commercial Distribution

  • 00630414019796 ()
11219531

  • Haematological cell analyser IVD
ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH SINGLE ASPIRATE
Siemens Healthcare Diagnostics Inc.
11219530
In Commercial Distribution

  • 00630414019789 ()
11219530

  • Haematological cell analyser IVD
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