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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 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

BC von Willebrand Reagent - 00630414320366

Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination
Siemens Healthcare Diagnostics Products GmbH
10874080
In Commercial Distribution

  • 00842768018800 ()
  • 00630414320366 ()
10874080

  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

N Protein Standard SL - 00630414285061

N Protein Standard SL is a multi-analyte calibrator for the establishment of reference curves on the BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873692
In Commercial Distribution

  • 00630414285061 ()
  • 00630414287454 ()
OQIM19

  • Plasma protein IVD, calibrator

N Latex ADNase B (USA) - 00630414285054

Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873691
In Commercial Distribution

  • 00630414285054 ()
OWTI15

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent

N Latex Myoglobin - 00630414285047

Quantitative determination of myoglobin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873690
In Commercial Distribution

  • 00630414285047 ()
OWIA17

  • Myoglobin IVD, kit, nephelometry/turbidimetry

N Latex IgA - 00630414285030

Quantitative determination of IgA in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873689
In Commercial Distribution

  • 00630414285030 ()
OQAI15

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

N Lp(a) Control SY - 00630414285016

Assayed control for Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873687
In Commercial Distribution

  • 00630414287447 ()
  • 00630414285016 ()
OQCW07

  • Lipoprotein A IVD, control

N/T Rheumatology Control SL/2 - 00630414284996

Assayed control for RF, ASL and CRP assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873685
In Commercial Distribution

  • 00630414287423 ()
  • 00630414284996 ()
OQDC17

  • Rheumatoid factor IVD, control

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

IMMULITE 2000 Third Generation TSH - 00630414210834

TSH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11129118
In Commercial Distribution

  • 00630414210834 ()
L2KTS2(D)

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