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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 LP(a) Standard SY - 00630414285009

Calibration of Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873686
In Commercial Distribution

  • 00630414287430 ()
  • 00630414285009 ()
OQCV07

  • Lipoprotein A IVD, calibrator

N Rheumatology Standard SL - 00630414284972

Calibration of RF, ASL and CRP assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873683
In Commercial Distribution

  • 00630414287409 ()
  • 00630414284972 ()
OQKZ15

  • Rheumatoid factor IVD, calibrator

INNOVANCE Anti-Xa - 00630414240404

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 - 00630414240343

INNOVANCE Apixaban Standards
Siemens Healthcare Diagnostics Products GmbH
10873675
In Commercial Distribution

  • 00630414240343 ()
OPPW05

  • Coagulation factor Xa inhibitor IVD, calibrator

INNOVANCE Apixaban Controls - 00630414240336

INNOVANCE Apixaban Controls
Siemens Healthcare Diagnostics Products GmbH
10873674
In Commercial Distribution

  • 00630414240336 ()
OPPV05

  • Coagulation factor Xa inhibitor IVD, control

N FLC CONTROL SL2 - 00630414237503

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

N FLC STANDARD SL - 00630414237497

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

N FLC CONTROL SL1 - 00630414237480

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

N FLC SUPPLEMENTARY REAGENT - 00630414237473

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 2000 Third Generation TSH - 00630414210841

TSH - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11129119
In Commercial Distribution

  • 00630414210841 ()
L2KTS6(D)

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
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