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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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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

INNOVANCE® D-Dimer Controls - 00842768023668

INNOVANCE® D-Dimer Control 1 and Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on Siemens and Sysmex® Systems
Siemens Healthcare Diagnostics Products GmbH
10446006
In Commercial Distribution

  • 00842768023668 ()
OPDY09

  • D-dimer IVD, control

MI View&GO - 04068151027013

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA3
In Commercial Distribution

  • 04068151027013 ()


  • PET system application software
  • SPECT system application software

ACUSON Origin ICE Diagnostic Ultrasound System - 04068151012477

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11669400
In Commercial Distribution

  • 04068151012477 ()


  • General-purpose ultrasound imaging system

HLX Transducer - 04068151010022

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11575216
In Commercial Distribution

  • 04068151010022 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
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