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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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Dimension Vista® Soluble Transferrin Receptor Flex® reagent cartridge - 00842768006241

For the quantitative measurement of soluble transferrin receptor in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445909
In Commercial Distribution

  • 00842768006241 ()
  • 00842768020162 ()
K7070

  • Soluble transferrin receptor IVD, reagent

Dimension Vista® Rheumatoid Factors Flex® reagent cartridge - 00842768006234

For the quantitative measurement of rheumatoid factor in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445908
In Commercial Distribution

  • 00842768006234 ()
  • 00842768020155 ()
K7068

  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry

DImension Vista® Microalbumin Flex® reagent cartridge - 00842768006203

For the quantitative measurement of albumin in human urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445905
In Commercial Distribution

  • 00842768006203 ()
  • 00842768020124 ()
K7062

  • Albumin IVD, kit, nephelometry/turbidimetry

DImension Vista® Immunoglobulin M Flex® reagent cartridge - 00842768006197

For the quantitative measurement of immunoglobulin M in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445904
In Commercial Distribution

  • 00842768006197 ()
  • 00842768020100 ()
K7058

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Dade® Ci-Trol® Coagulation Control Level 3 - 00842768004070

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445733
In Commercial Distribution

  • 00842768004070 ()
  • 00842768019456 ()
B4244-30

  • Multiple coagulation factor IVD, control

Dade® Ci-Trol® Coagulation Control Level 2 - 00842768004063

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445732
In Commercial Distribution

  • 00842768004063 ()
  • 00842768019463 ()
B4244-20

  • Multiple coagulation factor IVD, control

Dade® Ci-Trol® Coagulation Control Level 1 - 00842768004056

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445731
In Commercial Distribution

  • 00842768004056 ()
  • 00842768019470 ()
B4244-10

  • Multiple coagulation factor IVD, control

Dade® Hepzyme® - 00842768004049

Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10445730
In Commercial Distribution

  • 00842768004049 ()
  • 00842768019487 ()
B4240-10

  • Coagulation inhibitory substance neutralization IVD, reagent

Factor VIII Chromogenic Assay - 00842768004032

Determination of Factor VIII (antihemophilic factor) activity in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445729
In Commercial Distribution

  • 00842768004032 ()
B4238-40

  • Coagulation factor VIII IVD, kit, chromogenic

Dade® Cluster® Platelet Aggregation Reagents - 00842768003998

For use in platelet aggregometry studies
Siemens Healthcare Diagnostics Products GmbH
10445725
In Commercial Distribution

  • 00842768003998 ()
B4236-1

  • Platelet aggregation study IVD, kit, nephelometry/turbidimetry
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