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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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C1IN CON is an assayed, mid level, intralaboratory quality control for the assessment of precision and analytical bias in the determination of the C1IN method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445927
Not in Commercial Distribution

  • 00842768006418 ()
  • 00842768019340 ()
KC745

  • Plasma protein IVD, control
For the calibration of the C1IN method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445926
Not in Commercial Distribution

  • 00842768006401 ()
  • 00842768019357 ()
KC740

  • Plasma protein IVD, calibrator
CYSC CON H is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of the CYSC method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445925
In Commercial Distribution

  • 00842768006395 ()
  • 00842768019364 ()
KC737

  • Plasma protein IVD, control
APO CON is an assayed intralaboratory quality control for the assessment of precision and analytical bias in the determination of APOAI and APOB methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445923
In Commercial Distribution

  • 00842768006371 ()
  • 00842768019388 ()
KC725

  • Plasma protein IVD, control
PROT1 CON H is an assayed, high level ,intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445921
In Commercial Distribution

  • 00842768006357 ()
  • 00842768019401 ()
KC717

  • Plasma protein IVD, control
For the quantitative measurement of hemopexin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445916
Not in Commercial Distribution

  • 00842768006319 ()
  • 00842768020254 ()
K7088

  • Haemopexin IVD, reagent
For the quantitative measurement of immunoglobulin G subclass 4 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445914
In Commercial Distribution

  • 00842768006296 ()
  • 00842768020230 ()
K7083

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
For the quantitative measurement of immunoglobulin G subclass 2 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445912
In Commercial Distribution

  • 00842768006272 ()
  • 00842768020193 ()
K7081

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
For the quantitative measurement of immunoglobulin G subclass 1 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445911
In Commercial Distribution

  • 00842768006265 ()
  • 00842768020186 ()
K7080

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
For the quantitative measurement of transferrin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445910
In Commercial Distribution

  • 00842768006258 ()
  • 00842768020179 ()
K7072

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of soluble transferrin receptor in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445909
In Commercial Distribution

  • 00842768006241 ()
  • 00842768020162 ()
K7070

  • Soluble transferrin receptor IVD, reagent
For the quantitative measurement of rheumatoid factor in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445908
In Commercial Distribution

  • 00842768006234 ()
  • 00842768020155 ()
K7068

  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of retinol binding protein in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445907
Not in Commercial Distribution

  • 00842768006227 ()
  • 00842768020148 ()
K7066

  • Retinol binding protein IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of Prealbumin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445906
In Commercial Distribution

  • 00842768006210 ()
  • 00842768020131 ()
K7064

  • Collagen pyridium crosslink IVD, reagent
For the quantitative measurement of albumin in human urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445905
In Commercial Distribution

  • 00842768006203 ()
  • 00842768020124 ()
K7062

  • Albumin IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin M in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445904
In Commercial Distribution

  • 00842768006197 ()
  • 00842768020100 ()
K7058

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin G in human serum, plasma and cerebrospinal fluid (CSF) an urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445903
In Commercial Distribution

  • 00842768006180 ()
  • 00842768020094 ()
K7056

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or EDTA) on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445902
In Commercial Distribution

  • 00842768006173 ()
  • 00842768020087 ()
K7054

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin A in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445901
In Commercial Distribution

  • 00842768006166 ()
  • 00842768020070 ()
K7052

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of C-reactive protein in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445898
In Commercial Distribution

  • 00842768006135 ()
  • 00842768020049 ()
K7046

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
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