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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®Apolipoprotein B Flex® reagent cartridge - 00842768006029

For the quantitative measurement of apolipoprotein B in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445887
In Commercial Distribution

  • 00842768006029 ()
  • 00842768019906 ()
K7020

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

Dimension Vista® Apolipoprotein AI Flex® reagent cartridge - 00842768006012

For the quantitative measurement of apolipoprotein A-I in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445886
In Commercial Distribution

  • 00842768006012 ()
  • 00842768019890 ()
K7018

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Dimension Vista®a1-Antitrypsin Flex® reagent cartridge - 00842768005992

For the quantitative measurement of a1-antitrypsin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445884
In Commercial Distribution

  • 00842768005992 ()
  • 00842768019876 ()
K7014

  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry

Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridge - 00842768005985

For the quantitative measurement of a1-acid glycoprotein (Orosomucoid) in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445883
In Commercial Distribution

  • 00842768005985 ()
  • 00842768019869 ()
K7012

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

Dimension Vista® a1-Microglobulin Flex® reagent cartridge - 00842768005978

For the quantitative measurement of a1-microglobulin in human urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445882
Not in Commercial Distribution

  • 00842768005978 ()
  • 00842768019852 ()
K7010

  • Alpha-1-microglobulin 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
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