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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® C1 Inhibitor Control - 00842768006418

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

DImension Vista® C1 Inhibitor Calibrator - 00842768006401

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

DImension Vista® Cystatin C Control H (high) - 00842768006395

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

DImension Vista® Apolipoprotein Control - 00842768006371

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

DImension Vista® Protein 1 Control H (high) - 00842768006357

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

DImension Vista® Hemopexin Flex® reagent cartridge - 00842768006319

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

DImension Vista® Immunoglobulin G Subclass 4 Flex® Reagent Cartridge - 00842768006296

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

DImension Vista® Immunoglobulin G Subclass 2 Flex® reagent cartridge - 00842768006272

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

DImension Vista® Immunoglobulin G Subclass 1 Flex® reagent cartridge - 00842768006265

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

DImension Vista® Transferrin Flex® reagent cartridge - 00842768006258

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

Dimension Vista® Soluble Transferrin Receptor Flex® reagent cartridge - 00842768006241

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

Dimension Vista® Rheumatoid Factors Flex® reagent cartridge - 00842768006234

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

DImension Vista® Retinol binding Protein - 00842768006227

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

DImension Vista® Prealbumin Flex® reagent cartridge - 00842768006210

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

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

Dimension Vista® C-Reactive Protein Flex® reagent cartridge - 00842768006081

For the quantitative measurement of C-reactive protein in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445893
In Commercial Distribution

  • 00842768006081 ()
  • 00842768019982 ()
K7032

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

Dimension Vista® Ceruloplasmin Flex® reagent cartridge - 00842768006074

For the quantitative measurement of ceruloplasmin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445892
In Commercial Distribution

  • 00842768006074 ()
  • 00842768019975 ()
K7030

  • Ceruloplasmin IVD, kit, nephelometry/turbidimetry

Dimension Vista® C4 Complement Flex® reagent cartridge - 00842768006067

For the quantitative measurement of C4 complement in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445891
In Commercial Distribution

  • 00842768006067 ()
  • 00842768019968 ()
K7028

  • Complement components C4/C4c IVD, kit, nephelometry/turbidimetry

Dimension Vista® C3 Complement Flex® reagent cartridge - 00842768006050

For the quantitative measurement of C3 complement in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445890
In Commercial Distribution

  • 00842768006050 ()
  • 00842768019951 ()
K7026

  • Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

Dimension Vista® ß2-Microglobulin Flex® reagent cartridge - 00842768006043

For the quantitative measurement of ß2-microglobulin in human serum, plasma and urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445889
In Commercial Distribution

  • 00842768006043 ()
K7024

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

Dimension Vista®Antistreptolysin O Flex® reagent cartridge - 00842768006036

For the quantitative measurement of antistreptolysin O in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445888
In Commercial Distribution

  • 00842768006036 ()
  • 00842768019944 ()
K7022

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

Dimension Vista®Apolipoprotein B Flex® reagent cartridge - 00842768006029

For the quantitative measurement of apolipoprotein B in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445887
In Commercial Distribution

  • 00842768006029 ()
  • 00842768019906 ()
K7020

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

Dimension Vista® Apolipoprotein AI Flex® reagent cartridge - 00842768006012

For the quantitative measurement of apolipoprotein A-I in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445886
In Commercial Distribution

  • 00842768006012 ()
  • 00842768019890 ()
K7018

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Dimension Vista®a1-Antitrypsin Flex® reagent cartridge - 00842768005992

For the quantitative measurement of a1-antitrypsin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445884
In Commercial Distribution

  • 00842768005992 ()
  • 00842768019876 ()
K7014

  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry

Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridge - 00842768005985

For the quantitative measurement of a1-acid glycoprotein (Orosomucoid) in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445883
In Commercial Distribution

  • 00842768005985 ()
  • 00842768019869 ()
K7012

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

Dimension Vista® a1-Microglobulin Flex® reagent cartridge - 00842768005978

For the quantitative measurement of a1-microglobulin in human urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445882
Not in Commercial Distribution

  • 00842768005978 ()
  • 00842768019852 ()
K7010

  • Alpha-1-microglobulin IVD, kit, nephelometry/turbidimetry

Dade® Ci-Trol® Coagulation Control Level 3 - 00842768004070

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445733
In Commercial Distribution

  • 00842768004070 ()
  • 00842768019456 ()
B4244-30

  • Multiple coagulation factor IVD, control

Dade® Ci-Trol® Coagulation Control Level 2 - 00842768004063

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445732
In Commercial Distribution

  • 00842768004063 ()
  • 00842768019463 ()
B4244-20

  • Multiple coagulation factor IVD, control

Dade® Ci-Trol® Coagulation Control Level 1 - 00842768004056

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445731
In Commercial Distribution

  • 00842768004056 ()
  • 00842768019470 ()
B4244-10

  • Multiple coagulation factor IVD, control

Dade® Hepzyme® - 00842768004049

Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10445730
In Commercial Distribution

  • 00842768004049 ()
  • 00842768019487 ()
B4240-10

  • Coagulation inhibitory substance neutralization IVD, reagent

Factor VIII Chromogenic Assay - 00842768004032

Determination of Factor VIII (antihemophilic factor) activity in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445729
In Commercial Distribution

  • 00842768004032 ()
B4238-40

  • Coagulation factor VIII IVD, kit, chromogenic
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