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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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DImension Vista® Microalbumin Flex® reagent cartridge - 00842768006203

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

DImension Vista® Immunoglobulin M Flex® reagent cartridge - 00842768006197

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

DImension Vista® Immunoglobulin G Flex® reagent cartridge - 00842768006180

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

DImension Vista® Immunoglobulin E Flex® reagent cartridge - 00842768006173

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

DImension Vista® Immunoglobulin A Flex® reagent cartridge - 00842768006166

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

Dimension Vista hsCRP Flex reagent cartridge - 00842768006135

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

DImension Vista® Homocysteine Flex® reagent cartridge - 00842768006128

For the quantitative measurement of total homocysteine in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445897
In Commercial Distribution

  • 00842768006128 ()
  • 00842768020032 ()
K7044

  • Homocysteine IVD, reagent

DImension Vista® Haptoglobin Flex® reagent cartridge - 00842768006111

For the quantitative measurement of haptoglobin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445896
In Commercial Distribution

  • 00842768006111 ()
  • 00842768020025 ()
K7042

  • Haptoglobin IVD, kit, nephelometry/turbidimetry

DImension Vista® Cystatin C Flex® reagent cartridge - 00842768006104

For the quantitative measurement of cystatin C in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445895
In Commercial Distribution

  • 00842768006104 ()
  • 00842768020001 ()
K7040

  • Cystatin C IVD, kit, nephelometry/turbidimetry

DImension Vista® sALB Flex® reagent cartridgeSpecialty Albumin - 00842768006098

For the quantitative measurement of albumin in human serum and plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445894
In Commercial Distribution

  • 00842768006098 ()
  • 00842768019999 ()
K7034

  • Albumin IVD, kit, nephelometry/turbidimetry
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