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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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Emit II Plus Oxycodone Positive Control 100
Siemens Healthcare Diagnostics Inc.
10720810
In Commercial Distribution

  • 00630414027999 ()
9T619UL

  • Oxycodone IVD, control
Emit II Plus Oxycodone Negative Control 300
Siemens Healthcare Diagnostics Inc.
10720811
In Commercial Distribution

  • 00630414027982 ()
9T709UL

  • Oxycodone IVD, control
Emit II Plus Oxycodone Positive Control 300
Siemens Healthcare Diagnostics Inc.
10720812
In Commercial Distribution

  • 00630414027975 ()
9T719UL

  • Oxycodone IVD, control
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
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