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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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For use in daily maintenance of the IMMULITE® and IMMULITE® 1000 systems
Siemens Healthcare Diagnostics Products GmbH
10385332
In Commercial Distribution

  • 00842768028441 ()
LKPM

  • Wash/cleaning solution IVD, automated/semi-automated system
For use in daily maintenance of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers
Siemens Healthcare Diagnostics Products GmbH
10385229
In Commercial Distribution

  • 00842768028434 ()
L2KPM

  • Wash/cleaning solution IVD, automated/semi-automated system
For use in the routine operation of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers
Siemens Healthcare Diagnostics Products GmbH
10385231
In Commercial Distribution

  • 00842768028427 ()
  • 00842768019708 ()
L2PWSM

  • Wash/cleaning solution IVD, automated/semi-automated system
For use in the routine operation of the IMMULITE® and IMMULITE® 1000 Analyzers
Siemens Healthcare Diagnostics Products GmbH
10385393
In Commercial Distribution

  • 00842768028410 ()
  • 00842768019760 ()
LPWS2

  • Wash/cleaning solution IVD, automated/semi-automated system
For the quantitative determination of von Willenbrand factor (VWF) GPIb-binding activity in human sodium citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10487040
In Commercial Distribution

  • 00842768028014 ()
OPHL035

  • von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry
For use in conjunction with INNOVANCE D-Dimer to dilute samples
Siemens Healthcare Diagnostics Products GmbH
10487039
In Commercial Distribution

  • 00842768027611 ()
  • 00842768019265 ()
OPBR03

  • Buffered sample diluent IVD
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
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
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
To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10444868
In Commercial Distribution

  • 00842768024870 ()
B4170-00

  • Platelet aggregation analyser IVD
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