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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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N FLC Control SL1 - 00842768031458

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

N FLC Standard SL - 00842768031441

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

N FLC Supplementary Reagent - 00842768031434

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

N Diluent - 00842768030239

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

N Antiserum to Human a2-Macroglobulin - 00842768029967

Quantitative determination of a2-macroglobulin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10469773
In Commercial Distribution

  • 00842768029967 ()
OSAM21

  • Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry

INNOVANCE VWF Ac - 00842768028014

For the quantitative determination of von Willenbrand factor (VWF) GPIb-binding activity in human sodium citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10487040
In Commercial Distribution

  • 00842768028014 ()
OPHL035

  • von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry

INNOVANCE® D-Dimer Sample Diluent - 00842768027611

For use in conjunction with INNOVANCE D-Dimer to dilute samples
Siemens Healthcare Diagnostics Products GmbH
10487039
In Commercial Distribution

  • 00842768027611 ()
  • 00842768019265 ()
OPBR03

  • Buffered sample diluent IVD

INNOVANCE® Antithrombin - 00842768027024

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10487304
In Commercial Distribution

  • 00842768027024 ()
OPFH07

  • Antithrombin III (ATIII) IVD, kit, chromogenic

INNOVANCE® Antithrombin - 00842768027017

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10487303
In Commercial Distribution

  • 00842768027017 ()
OPFH09

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Standard Human Plasma - 00842768026812

Standard Human Plasma for the calibration of coagulation and fibrinolysis tests
Siemens Healthcare Diagnostics Products GmbH
10487098
In Commercial Distribution

  • 00842768026812 ()
  • 00842768018893 ()
ORKL19

  • Multiple coagulation factor IVD, calibrator
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