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

  • 00842768003981 ()
  • 00842768019494 ()
B4234-25

  • Buffered sample diluent IVD
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
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
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
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
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
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
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
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
Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination
Siemens Healthcare Diagnostics Products GmbH
10714565
In Commercial Distribution

  • 00842768038211 ()
  • 00842768018800 ()
OUBD39

  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent
Quantitative determination of albumin in human serum, plasma, urine and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10714509
In Commercial Distribution

  • 00842768038020 ()
OSAL25

  • Albumin IVD, kit, nephelometry/turbidimetry
Quantitative determination of albumin in human serum, plasma, urine and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10714508
In Commercial Distribution

  • 00842768038013 ()
OSAL23

  • Albumin IVD, kit, nephelometry/turbidimetry
Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10709521
In Commercial Distribution

  • 00842768037146 ()
OPFH11

  • Antithrombin III (ATIII) IVD, kit, chromogenic
Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasma from individuals with the Factor V (Leiden) defect
Siemens Healthcare Diagnostics Products GmbH
10459420
In Commercial Distribution

  • 00842768033520 ()
OQYI11

  • Activated protein C resistance ratio (APCR) IVD, kit, clotting
Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10482442
In Commercial Distribution

  • 00842768031465 ()
  • 04056869221960 ()
OPJF03

  • Kappa/lambda light chain immunoglobulin IVD, control
Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10482441
In Commercial Distribution

  • 00842768031458 ()
  • 04056869221953 ()
OPJE03

  • Kappa/lambda light chain immunoglobulin IVD, control
Establishment of reference curves for the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10482440
In Commercial Distribution

  • 00842768031441 ()
  • 04056869221946 ()
OPJD03

  • Kappa/lambda light chain immunoglobulin IVD, calibrator
Quantitative determination of free light chains (FLC) type kappa and type lambda in human serum and EDTA-plasma on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10482439
In Commercial Distribution

  • 00842768031434 ()
OPJC03

  • Kappa/lambda light chain immunoglobulin IVD, reagent
Solution for preparing dilutions for immunochemical determinations with the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10469513
In Commercial Distribution

  • 00842768030239 ()
  • 00842768020261 ()
OUMT05

  • Buffered sample diluent IVD
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