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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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INNOVANCE® D-Dimer Sample Diluent - 00842768027611

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

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

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

PFA-100® System - 00842768024870

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

Dimension Vista® PROT3 CON - 00842768024498

PROT3 CON is an assayed, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10465668
In Commercial Distribution

  • 00842768024498 ()
  • 00842768019302 ()
KC775U

  • Plasma protein IVD, control

Dimension Vista® PROT1 CAL - 00842768024443

PROT1 CAL is a multi-analyte calibrator for the use on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10465664
In Commercial Distribution

  • 00842768024443 ()
  • 00842768019449 ()
KC710U

  • Plasma protein IVD, calibrator

Dimension Vista® Flex® reagent cartridge LAMBDA - 00842768024436

For the quantitative measurement of immunoglobulin light chains, type lambda in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10465672
In Commercial Distribution

  • 00842768024436 ()
  • 00842768020063 ()
K7051

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

Dimension Vista® Flex® reagent cartridge KAPPA - 00842768024429

For the quantitative measurement of immunoglobulin light chains, type kappa in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10465671
In Commercial Distribution

  • 00842768024429 ()
  • 00842768020056 ()
K7049

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

Dimension Vista® Flex® reagent cartridge A2MAC - 00842768024412

For the quantitative measurement of a2-macroglobulin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10465670
Not in Commercial Distribution

  • 00842768024412 ()
  • 00842768019883 ()
K7017

  • Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry
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