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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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In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma.
Siemens Healthcare Diagnostics Products GmbH
10873681
In Commercial Distribution

  • 00630414240404 ()
OPPU05

  • Coagulation factor Xa inhibitor/heparin activity reagent kit IVD
INNOVANCE Apixaban Standards
Siemens Healthcare Diagnostics Products GmbH
10873675
In Commercial Distribution

  • 00630414240343 ()
OPPW05

  • Coagulation factor Xa inhibitor IVD, calibrator
INNOVANCE Apixaban Controls
Siemens Healthcare Diagnostics Products GmbH
10873674
In Commercial Distribution

  • 00630414240336 ()
OPPV05

  • Coagulation factor Xa inhibitor IVD, control
Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems.
Siemens Healthcare Diagnostics Products GmbH
10873663
In Commercial Distribution

  • 00630414237503 ()
  • 00630414246406 ()
OPJF05

  • 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 BN Systems.
Siemens Healthcare Diagnostics Products GmbH
10873662
In Commercial Distribution

  • 00630414237497 ()
  • 00630414246390 ()
OPJD05

  • Kappa/lambda light chain immunoglobulin IVD, calibrator
Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems.
Siemens Healthcare Diagnostics Products GmbH
10873661
In Commercial Distribution

  • 00630414237480 ()
  • 00630414246383 ()
OPJE05

  • Kappa/lambda light chain immunoglobulin IVD, control
Immunonephelometric determination of free light chains (FLC) type kappa and type lambda on BN Systems.
Siemens Healthcare Diagnostics Products GmbH
10873660
In Commercial Distribution

  • 00630414237473 ()
OPJC05

  • Kappa/lambda light chain immunoglobulin IVD, reagent
IMMULITE(R) 2000 TSI CVM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10715502
In Commercial Distribution

  • 00630414006680 ()
L2SICVM

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, control
rPru av 1 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471072
In Commercial Distribution

  • 00630414006345 ()
A597L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
rMal d 4 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471077
In Commercial Distribution

  • 00630414006291 ()
A796L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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