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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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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

Dade® Owren's Veronal Buffer - 00842768003981

Dilution buffer for coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10445724
In Commercial Distribution

  • 00842768003981 ()
  • 00842768019494 ()
B4234-25

  • Buffered sample diluent IVD

Dade® DIMERTEST® Latex Beads - 00842768003974

For use with DIMERTEST® Latex kit for the rapid qualitative or semiquantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445723
Not in Commercial Distribution

  • 00842768003974 ()
B4233-61L

  • D-dimer IVD, reagent

Dade® DIMERTEST® Latex Assay - 00842768003967

The DIMERTEST® Latex Assay is intended for the rapid qualitative or semiquantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445722
Not in Commercial Distribution

  • 00842768003967 ()
B4233-60

  • D-dimer IVD, kit, agglutination

Dade® Thrombin Reagent - 00842768003950

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10445721
In Commercial Distribution

  • 00842768003950 ()
  • 00842768019500 ()
B4233-27

  • Fibrinogen assay (factor I) IVD, reagent

Dade® Thrombin Reagent - 00842768003943

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10445720
In Commercial Distribution

  • 00842768003943 ()
  • 00842768019517 ()
B4233-25

  • Fibrinogen assay (factor I) IVD, reagent

Dade® Data-Fi® Abnormal Fibrinogen Control - 00842768003936

Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low range
Siemens Healthcare Diagnostics Products GmbH
10445719
In Commercial Distribution

  • 00842768003936 ()
  • 00842768019524 ()
B4233-22

  • Fibrinogen assay (factor I) IVD, control

Dade® Fibrinogen Determination Reagents - 00842768003929

Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445718
Not in Commercial Distribution

  • 00842768003929 ()
B4233-15SY

  • Fibrinogen assay (factor I) IVD, kit, clotting

INNOVANCE Free PS Ag - 00842768039522

For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer.
Siemens Healthcare Diagnostics Products GmbH
10873458
In Commercial Distribution

  • 00842768039522 ()
OPGL07

  • Protein S IVD, kit, nephelometry/turbidimetry

Dade® CA System Buffer - 00842768039416

For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873440
In Commercial Distribution

  • 00842768039416 ()
  • 00842768019845 ()
B4265-37

  • Buffered sample diluent IVD
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