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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® 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® Actin® FSL Activated PTT Reagent - 00842768003882

Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445714
In Commercial Distribution

  • 00842768003882 ()
  • 00842768019555 ()
B4219-2

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® FS Activated PTT Reagent - 00842768003868

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445712
In Commercial Distribution

  • 00842768003868 ()
  • 00842768019562 ()
B4218-20

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® FS Activated PTT Reagent - 00842768003844

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445710
In Commercial Distribution

  • 00842768003844 ()
  • 00842768019562 ()
B4218-100

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Innovin® - 00842768003806

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10445706
Not in Commercial Distribution

  • 00842768003806 ()
  • 00842768019586 ()
B4212-50

  • Prothrombin time (PT) IVD, reagent

Dade® Innovin® - 00842768003790

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10445705
Not in Commercial Distribution

  • 00842768003790 ()
  • 00842768019593 ()
B4212-40

  • Prothrombin time (PT) IVD, reagent

Dade® Innovin® - 00842768003783

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10445704
Not in Commercial Distribution

  • 00842768003783 ()
  • 00842768019609 ()
B4212-100

  • Prothrombin time (PT) IVD, reagent

Dade® PFA Trigger Solution - 00842768003691

To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10445701
In Commercial Distribution

  • 00842768003691 ()
  • 00842768019791 ()
B4170-50

  • Platelet aggregation study IVD, reagent

Dade® PFA Collagen/ADP Test Cartridge - 00842768003684

To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10445699
In Commercial Distribution

  • 00842768003684 ()
  • 00842768019784 ()
B4170-21A

  • Platelet aggregation study IVD, reagent

Dade® PFA Collagen/EPI Test Cartridge - 00842768003660

To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10445697
In Commercial Distribution

  • 00842768003660 ()
  • 00842768019777 ()
B4170-20A

  • Platelet aggregation study IVD, reagent
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